Clinical Researcher
Clinical Research Coordinator Job 21 miles from Ocala
Outlier helps the world's most innovative companies improve their AI models by providing human feedback. Are you an experienced Biology who would like to lend your expertise to train AI models? About the opportunity: Outlier is looking for talented accounting and tax experts to help train generative artificial intelligence models This freelance opportunity is remote and hours are flexible, so you can work whenever is best for you You may contribute your expertise by…Assessing the factuality and relevance of domain-specific text produced by AI models Crafting and answering questions related to BiologyEvaluating and ranking domain-specific responses generated by AI models Examples of desirable expertise:A bachelor's or higher degree in Biology or a related subject Experience working as an Biology professional Ability to write clearly about concepts related to Biology in fluent EnglishPayment:Currently, pay rates for core project work by Biology experts range from $30 to $50 per hour USD.
Rates vary based on expertise, skills assessment, location, project need, and other factors.
For example, higher rates may be offered to PhDs.
For non-core work, such as during initial project onboarding or project overtime phases, lower rates may apply.
Certain projects offer incentive payments.
Please review the payment terms for each project.
Clinical Systems Operations Specialist I
Clinical Research Coordinator Job 43 miles from Ocala
**About us:** At Thermo Fisher Scientific, our mission is to enable our customers to make the world healthier, cleaner, and safer. With a team spanning 125,000+ colleagues worldwide, we share a common set of values - Integrity, Intensity, Innovation, and Involvement.
Together, we accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. Our commitment to diversity and inclusion means that we value diverse experiences, backgrounds, and perspectives, creating a collaborative and inclusive environment where everyone can thrive.
PPD, the clinical research business of Thermo Fisher Scientific, has a new opening for a **Clinical Systems Operations Specialist I.** This role is remotely based on the east coast of the United States and is an integral part of our global Patient First Digital Solutions, Quality Control (QC) team. The Specialist function is to coordinate the quality control of study configurations in Clinical Trial Management Systems (CTMS), eSource and other systems used in clinical trials.
**What you will do:**
+ Coordinate the global study configuration QC process. Handles all elements of quality checks at a study level, including but not limited to understanding and following SOP's and work instructions, documentation, communication, risk identification and adherence to timelines.
+ Identifies, researches, and resolves technical problems
+ Ensures study configuration accurately represents protocol requirements, study budget, and site network needs.
+ Ensures study configuration is prepared in accordance with ICH-GCP, FDA and other applicable regulatory guidelines.
+ Liaises on quality findings at the site level and coordinates and communicates resolutions with manager and collaborators.
+ Works with study builders to ensure understanding of the design and study requirements prior to undertaking QC activities.
+ Delivers study configuration QC to staff within appropriate timelines.
+ Able to identify industry and site-level standards and implement them for study configuration design and builds.
+ Able to handle a high workload of variable tasks, ensuring ownership and timely delivery of all assignments.
+ Identify and communicate opportunities for process improvements back to manager
**Education and Experience** :
+ Bachelor's degree or equivalent and relevant formal academic / vocational qualification
+ Previous clinical operations experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3-5 years' experience)
+ Experience of medical terminology, clinical research protocols, clinical study budgets/contracts, and study documentation
+ In some cases an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
**Knowledge, Skills and Abilities:**
+ In-depth knowledge of study configuration processes
+ Ability to exercise judgment and decision making
+ Excellent problem-solving abilities
+ Ability to work independently and keep up with rapid changes in priorities
+ Organized with strong time management skills
+ Knowledge of PFDS study processes and site network requirements
+ Ability to use software to develop organized information and to provide a variety of reports. Ability to learn new software, systems and terminology
+ Excellent attention to detail
+ Strong project management skills, including English communication skills.
+ Strong collaboration skills and positive demeanor
+ Ability to handle a high workload and ensure timely delivery
At Thermo Fisher Scientific, we are committed to fostering a healthy and harmonious workplace for our employees. We understand the importance of creating an environment that allows individuals to excel. Please see below for the required qualifications for this position, which also includes the possibility of equivalent experience:
+ Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
+ Able to work upright and stationary for typical working hours.
+ Ability to use and learn standard office equipment and technology with proficiency.
+ Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
+ May require as-needed travel (0-20%).
Salary Transparency
This is a salaried role that will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Compensation will be initially discussed during the screening period, with actual compensation confirmed in writing at the time of offer.
Accessibility/Disability Access
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
EEO & Affirmative Action
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
**Compensation and Benefits**
The salary range estimated for this position based in North Carolina is $60,000.00-$90,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs
+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement
+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
+ Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: *****************************************************
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Sr. Clinical Research Scientist
Clinical Research Coordinator Job 43 miles from Ocala
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you'll love working at Axogen:
* Friendly, open, and fun team culture that values unique perspectives
* Company-wide dedication to profoundly impacting patients' lives
* Comprehensive, high-quality benefits package effective on date of hire
* Educational assistance available for all employees
* Matching 401(k) retirement plan
* Paid holidays, including floating holidays, to be used at your discretion
* Employee Stock Purchase Plan
* Referral incentive program
If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: ******************************************
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Sr. Clinical Research Scientist
The Sr. Clinical Research Scientist will play a critical role in leading and managing clinical research activities, with a focus on advancing peripheral nerve science and its clinical applications. This position requires expertise in clinical trial design, data analysis, and regulatory submissions, ideally within the biotech or medical device industries. The successful candidate will collaborate cross-functionally to drive the development and execution of clinical strategies that support product efficacy, safety, and regulatory compliance.
Requirements of the Sr. Clinical Research Scientist
* Advanced degree (PhD, PharmD, MD) in life sciences, clinical research, biomedical engineering or a related field.
* Minimum 5 years of experience in clinical research in the biotech or medical device industry, including experience in leading clinical trials.
* In-depth knowledge of clinical trial design, regulatory requirements, and GCP.
* Experience with FDA submissions, including INDs, BLAs, PMAs, and/or 510(k)s.
* Strong leadership skills with the ability to work in cross-functional teams.
* Excellent written and verbal communication skills, including the ability to present complex clinical data to both scientific and non-scientific audiences.
Responsibilities of the Sr. Clinical Research Scientist
The specific duties of the Sr. Clinical Research Scientist include but are not limited to:
* Clinical Study Design and Protocol Development:
* Lead the design and development of clinical study protocols, including objectives, endpoints, sample size determination, and statistical analysis plans.
* Collaborate with cross-functional teams (regulatory, R&D, biostatistics, etc.) to align study design with regulatory strategies and product development goals.
* Contribute to the development of clinical strategies to support product claims and marketing.
* Clinical Study Execution:
* Oversee the execution of clinical studies, ensuring compliance with Good Clinical Practice (GCP), relevant regulations, and company standards.
* Provide scientific oversight and ensure clinical data integrity and quality throughout the study.
* Manage relationships with key opinion leaders (KOLs), investigators, and clinical research organizations (CROs).
* Data Analysis and Interpretation:
* Collaborate with biostatistics and data management teams to ensure accurate data analysis and reporting.
* Interpret clinical study results and generate clinical study reports, publications, and presentations.
* Provide scientific input on interim analyses, final analyses, and any safety-related issues that arise during the trial.
* Cross-Functional Collaboration:
* Work closely with R&D, regulatory affairs, quality, and commercial teams to ensure clinical program alignment with business objectives.
* Participate in project team meetings and provide clinical updates and scientific insights.
* Support product development by integrating clinical evidence into product design, development, and labeling.
* Scientific Communication and Publications:
* Develop and deliver scientific presentations at industry conferences, advisory boards, and internal meetings.
* Lead the preparation and submission of manuscripts for peer-reviewed journals, contributing to the company's scientific reputation.
* Compliance and Risk Management:
* Ensure compliance with all relevant clinical research guidelines, ethical standards, and regulatory requirements.
* Identify and mitigate risks related to clinical trial conduct, including patient safety, data integrity, and operational challenges.
* Innovation and Continuous Improvement:
* Stay updated on the latest trends, technologies, and methodologies in clinical research and the therapeutic area of focus.
* Drive process improvements in clinical operations, study design, and data management practices.
Location
13631 Progress Blvd., Alachua, FL 32615
OR
111 West Oak Ave., Tampa, FL 33602
OR
Remote
#LI-AC1
#LI-REMOTE
Benefits/Compensation
This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
Salary Range
$122,386-$152,982 USD
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
Clinical Research Site Manager
Clinical Research Coordinator Job In Ocala, FL
is incentive eligible. **Introduction** Are you passionate about the patient experience? At HCA Healthcare, we are committed to caring for patients with purpose and integrity. We care like family! Jump-start your career as a Clinical Research Site Manager today with HCA Florida Ocala Hospital.
**Benefits**
HCA Florida Ocala Hospital, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:
+ Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.
+ Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.
+ Free counseling services and resources for emotional, physical and financial wellbeing
+ 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service)
+ Employee Stock Purchase Plan with 10% off HCA Healthcare stock
+ Family support through fertility and family building benefits with Progyny and adoption assistance.
+ Referral services for child, elder and pet care, home and auto repair, event planning and more
+ Consumer discounts through Abenity and Consumer Discounts
+ Retirement readiness, rollover assistance services and preferred banking partnerships
+ Education assistance (tuition, student loan, certification support, dependent scholarships)
+ Colleague recognition program
+ Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence)
+ Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.
Learn more about Employee Benefits (**********************************************************************
**_Note: Eligibility for benefits may vary by location._**
Come join our team as a Clinical Research Site Manager. We care for our community! Just last year, HCA Healthcare and our colleagues donated $13.8 million dollars to charitable organizations. Apply Today!
**Job Summary and Qualifications**
The Site Manager is responsible for the overall clinical operations and management of a specified HCA Research Institute site and its affiliated physician groups. The Site Manager serves as a liaison with local investigators, hospital administration, and local research personnel.
**Duties include but are not limited to:**
Research Operations Management
+ Practices and adheres to the "Code of Conduct" philosophy and "Mission and Value Statement"
+ Oversee and manage routine operational activities of HRI site research staff
+ Liaise between site research personnel, industry sponsors, and HRI Division Director/leadership
+ Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable
+ Review proposed budgets for adequate coverage and recommends changes to Supervisor
+ Facilitate contracting with hospitals, provider groups, and/or vendors, as needed
+ Engage with revenue integrity to assist with reconciling study payments at the site
+ Actively engage in tracking of studies conducted at the site
+ Oversee study progress at the site from initial submission of feasibility until study closeout
+ Coordinate submission and approval for the Site's Facility Review Committee, if applicable
+ Manage HRI site team responsible for coordinating multiple research studies across several therapeutic areas
Site development:
+ Work with site personnel, local investigators, and hospital administration to assess site feasibility and resourcing for existing and upcoming research protocols
+ Assist in development and tracking of quarterly site goals
+ Regularly meet with physicians and administrators to assess site performance and investigator satisfaction
+ Provide a research update during Site Administrative meetings (Section meetings, Site Service Line meetings, etc.)
Reporting and Analysis:
+ Monitor patient enrollment at the site through weekly reports, and reports results to Supervisor
+ Communicate site status and site development through a monthly activity report
+ Facilitate continuing education and training to investigators and site research team members
+ Evaluate operational metrics to continuously improve study quality and/or improve processes
+ Complete performance evaluations for direct reports
**Education/Experience:**
+ Bachelor's Degree required; Master's Degree preferred
+ 5+ years of experience in healthcare, research, or other science related field
+ Complete performance evaluations for direct reports
**Licenses, Certifications, & Training:**
+ Research Certification (ACRP or CCRP) required
"The great hospitals will always put the patient and the patient's family first, and the really great institutions will provide care with warmth, compassion, and dignity for the individual."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder
If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Clinical Research Site Manager opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. **Unlock the possibilities and apply today!**
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
OPS Clinical Research Coordinator
Clinical Research Coordinator Job 37 miles from Ocala
The Research Coordinator will have various responsibilities related to: Preparation and/or Review of the Scientific Proposal, Regulatory and IRB Protocols, Conduct of Research, Reporting, and Project Closeout procedures. Preparation and/or Review of Scientific Proposal
* Assists the PI and research managers(s) in reviewing protocols
* Review of specific aims
* Perform study feasibility assessments
* Identify resources needed for participants
* Collaborates with the research manager(s) to prepare a categorized budget and justification.
Regulatory and IRB
* Reviews and comprehends the protocol.
* Collaborates with the PI and research manager(s) to prepare IRB and any other regulatory submission documents as required by the protocol.
* Prepares other study materials as requested by the PI/ research manager(s). These study materials include, but are not limited to, the informed consent document
* Ensures proper organization of study files, including but not limited to, regulatory binders, study specific source documentation and other materials by the research coordinator assigned to the investigation
* Maintenance of templates and examples of essential documents frequently used in the preparation of a protocol i.e. informed consent, telephone script
* Performs quality assurance ensuring proper maintenance of regulatory binder, protected health information and study documents
* Coordinates internal audits as deemed appropriate
Conduct of Research
* Supports clinical conduct of research and perform these duties as needed.
* Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
* Communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
* Collects documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
* Works with the PI/ research manager(s) to develop and implement recruitment strategies in accordance with IRB requirements and approvals.
* Conducts or participates in the informed consent process including interactions with the IRB, discussions with research participants, including answering any questions related to the protocol. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
* Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant's eligibility or exclusion.
* Coordinates participant tests and procedures.
* Collects data as required by the protocol. Assures timely completion of Case Report Forms.
* Maintains study timelines.
* Maintains adequate inventory of study supplies including Investigational Drug/Device Accountability.
* Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms, etc.
* Retains all study records in accordance with sponsor requirements and University policies and procedures.
* Maintains effective and ongoing communication with research participants, lead coordinator(s) and PI during the course of the study.
* Assists PI/ research manager(s) in preparation and submission of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.
* Works with the PI/lead coordinator(s) to manage the day-to-day activities of the study including problem solving, communication and protocol management.
Reporting
* Assists Principal Investigator and research manager(s) with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.
* Assists the research manager(s) and Principal Investigator to facilitate the registration of the study at ClinicalTrials.gov and maintains current information on the site (if appropriate).
Project Closeout
* Collaborates with the research manager(s) to facilitate the submission of accurate and timely closeout documents to applicable Federal agencies, University entities, and the sponsoring agency in accordance with Federal regulations and University and sponsoring agency policies and procedures.
* Ensures the secure storage of study documents that will be maintained according to University policy or for the contracted length of time, whichever is longer.
Performs other duties as assigned
Clinical Research Coordinator
Clinical Research Coordinator Job In Ocala, FL
Florida Cancer Affiliates is looking for a F/T, Clinical Research Coordinator to join our team! will support the Ocala offices in Ocala, Florida. Why work for us? We offer our employees a competitive benefits package that includes Medical, Dental, Vision, Life Insurance, Short-term and Long-term disability coverage, a generous PTO program, a 401k plan that comes with a company match, a Wellness program that rewards you practicing a healthy lifestyle, and lots of other great perks such as Tuition Reimbursement, an Employee Assistance program and discounts on some of your favorite retailers
Responsible for supporting the management and coordination of tasks for multiple clinical research studies to include screening patients for eligibility and participates in the subject's study visits and required activities per protocol. Duties include but not limited to assuring protocol compliance for all patients enrolled in the trial, participation in the informed consent process, perform ongoing assessments and documentation in collaboration with physicians and other providers, and participation in required training and education, Assures site research quality by practicing in compliance with US Oncology Research, Inc. (USOR) Standard Operating Procedures (SOP), principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations through OSHA, CDC and HIPPA. Supports and adheres to US Oncology Compliance Program, to include the Code of Ethics Business Standards.
Responsibilities
* Screens potential patients for protocol eligibility.
* Presents trial concepts and details to the patients, participates in the informed consent process, and enrolls patients on clinical trials.
* Assists with patient care in compliance with protocol requirements.
* May disburse investigational drug and maintain investigational drug accountability.
* Participates in data collection, entry, and reporting for the subjects. In collaboration with the physician, reviews patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly documents all findings.
* Participates in required training and education programs as well as monitoring and auditing activities. May work directly with sponsors. May participate in scheduling monitoring and auditing visits, as well as interact with the monitors/auditors while onsite. Assists with collection and maintenance of regulatory documents in accordance with USOR SOPs and applicable regulations. May assist in the packing and shipping of lab specimens to central vendors.
* May be required to complete Hazmat and/or IATA training.
Qualifications
* Minimum Job Qualifications: (Knowledge, Skills, & Abilities): Education/Training - Associate degree in a clinical or scientific related discipline required, Bachelor's degree preferred.
* Minimum one year of experience in a clinical or scientific related discipline, preferably in oncology required. Business Experience - Experience in Microsoft Office Experience working with physicians preferred Specialized Knowledge/Skills - Must have excellent communication skills Excellent organizational skills Strong ability to multi-task Excellent time management skills Must have strong interpersonal skills to be able to interact with multiple people on many different levels Must have a high level of attention to detail Must be able to work in a fast-paced environment May be responsible for basic clinical assessments Working Conditions: Environment (Office, warehouse, etc.) - Traditional office environment the work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Exposure to communicable diseases, toxic substances, ionizing radiation, medical preparations and other conditions common to an oncology/hematology clinic environment. Physical Requirements (Lifting, standing, etc.) - Large percent of time performing computer-based work is required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Requires standing and walking for extensive periods of time. Occasionally lifts and carries items weighing up to 40 lbs. Requires corrected vision and hearing to normal range. (This description is general in nature and is not intended to be an exhaustive list of all responsibilities. Other duties may be assigned as needed to meet company goals.
Clinical Research Coordinator
Clinical Research Coordinator Job 21 miles from Ocala
Clinical Research Coordinator works under Clinical Research Managers and are tasked with administering clinical trials. Responsibilities include managing clinical trials and collecting data, informing participants about study objectives, and administering questionnaires.
Requirements
ESSENTIAL JOB FUNCTION/COMPETENCIES
The responsibilities and duties described in this job description are intended to provide a general overview of the position. Duties may vary depending on the specific needs of the affiliate or location you are working at and/or state requirements. Responsibilities include but are not limited to:
Provide subject care and data collection procedures in adherence with the assigned study protocol and in accordance with good clinical research principals.
Review subject charts, database records, and other sources to screen and identify potential subjects for inclusion in study based on criteria described in the protocol.
Coordination and management of the clinical trial, communication with sponsor and authorities, visit coordination, sampling, time management and product accountability.
Data collection and management, collection and development of source documents, use of CRFs, managing patient registration, AEs, filing and archiving, managing monitoring visits, dealing with queries.
Maintain accurate records of the receipt, inventory, and dispensation of study drug and obtain and coordinate subject blood samples, cultures, tissues, and other specimens for laboratory analysis as described in study protocol.
Patient visits, data collection and transcription/EDC, prepare for monitor visits, protocol adherence to include height, weight, blood pressure, respirations, pulse temperature, O2 saturation.
Schedule appointments and organize materials to be used during study visits and ensure that all required tests are completed for each study visit per protocol.
Includes initial study start-up information/ requirements, dissemination of updated Investigator's Brochures, protocols and informed consent information, online training initiated by sponsor, review of correspondence throughout study.
Completes Source Documentation-which includes completing and uploading all necessary documents to CRIO and maintaining all charts properly.
Medical Assessment-includes obtaining information from patient or chart regarding name of medication, start and stop dates, dose, and indication.
Biological Sampling Collection/Packaging/Shipping - includes serum and/or tissue collection, processing, packaging and shipping per study specific requirements.
Case Report Form (CRF) Entries and Management - includes data entry, query resolution in paper and/or electronic CRFs.
Investigational Product (IP) Management - includes receiving IP supplies, IP accountability, monitoring of temperature controls, destructions or return of IP.
Develop and/or Maintain Essential Documents - includes study specific training documents, study specific logs, patient questionnaires, patient pill diaries, lab requisition forms, other study specific forms.
Supply Chain Maintenance-Supplies Inventoried, stocking, organizing, and resupply order placed as required. Completed in Envi system.
Study Coordination- rooming, administer questionnaires, scheduling scans, set up room for procedures and wipe and clean equipment after procedures and visits.
Obtain/Maintain all required training- GCP, IATA,CPR Occasionally help the study coordinators at other offices such as the surgery center.
Performs other position related duties as assigned.
Employees shall adhere to high standards of ethical conduct and will comply with and assist in complying with all applicable laws and regulations. This will include and not be limited to following the Solaris Health Code of Conduct and all Solaris Health and Affiliated Practice policies and procedures; maintaining the confidentiality of patients' protected health information in compliance with the Health Insurance Portability and Accountability Act (HIPAA); immediately reporting any suspected concerns and/or violations to a supervisor and/or the Compliance Department; and the timely completion the Annual Compliance Training.
CERTIFICATIONS, LICENSURES OR REGISTRY REQUIREMENTS
BLS certification required, ACLS preferred.
License and certification as required by state.
KNOWLEDGE | SKILLS | ABILITIES
Knowledge of medical terminology, healthcare coding systems, and clinics functions.
Must be able to function in a team-oriented environment, display strong analytical, investigative, interpersonal and organizational skills, pay high attention to detail with consistent follow-through and be able to productively manage high volumes of work.
Knowledge of database management.
Maintain a working knowledge of all assigned study protocols and amendments.
Excellent verbal and written communication skills.
Skill in using computer programs and applications including Microsoft Office.
Delivers exceptional patient service throughout all interactions.
Excellent organizational skills and attention to detail.
Strong analytical and problem-solving skills.
Complies with all health and safety policies of the organization.
Complies with HIPAA regulations for patient confidentiality.
Ability to work independently and manage deadlines.
Ability to establish and maintain effective working relationships with patients, colleagues, physicians and the public; successfully manages interactions with challenging or difficult people.
Ability to deal compassionately, professionally, and courteously with patients, their families, physicians, and staff.
Ability to build relationships with patients and display empathy and compassion to patients.
EDUCATION REQUIREMENTS
Bachelor's degree in a related field required (eg, biology, psychology, nursing or healthcare).
EXPERIENCE REQUIREMENTS
Experience with EPIC software preferred but not essential.
1-3 years of related experience preferred.
REQUIRED TRAVEL
Minimal travel required.
PHYSICAL DEMANDS
Carrying Weight Frequency
1-25 lbs. Frequent from 34% to 66%
26-50 lbs. Occasionally from 2% to 33%
Pushing/Pulling Frequency
1-25 lbs. Seldom, up to 2%
100 + lbs. Seldom, up to 2%
Lifting - Height, Weight Frequency
Floor to Chest, 1 -25 lbs. Occasional: from 2% to 33%
Floor to Chest, 26-50 lbs. Seldom: up to 2%
Floor to Waist, 1-25 lbs. Occasional: from 2% to 33%
Floor to Waist, 26-50 lbs. Seldom: up to 2%
OPS Research Coordinator for the Neurocognitive and Behavioral Development Laboratory (NBDL)
Clinical Research Coordinator Job 37 miles from Ocala
The research project will be conducted through a collaborative effort across the Department of Applied Physiology and Kinesiology, the UF Center for Autism and Related Disabilities (CARD; ********************** the Norman Fixel Institute for Neurological Diseases (***************************** and the UF Clinical and Translational Science Institute (CTSI) Human Imaging Core (*************************************************************************** Other off-campus partner sites include UCF CARD, USF CARD, and SPARK Research Match (********************************************************* This opportunity provides ample research and clinical training experience for post-baccalaureate candidates who plan to receive graduate training in clinical psychology, medical science, and rehabilitation science as the next step of the career advancement.
The position responsibilities include participant identification/recruitment (including in-state recruitment travel), administering cognitive, sensorimotor, clinical assessments and MRI testing, scoring data, data entry, managing IRB documentation, maintaining laboratory manuals, preparing progress reports to the NIH, participating in lab meetings (for recruitment, data quality control, and interpretation). The candidate shall anticipate gaining invaluable experience working with clinical populations, developing task administrative skills relevant to Neuroscience, Psychology, and Neurophysiology, and participating in each phase of the research process within a large-scale NIH-funded research project. Expected Salary:
Annual $37,000-$47,000 ( $18.00-$22.50 per hour); commensurate with experience
Minimum Requirements:
Bachelor's degree
Preferred Qualifications: Preferred candidates will have a BA or BS in Psychology, Neuroscience, Kinesiology, Health Science, or pre-health related field. The successful applicant must be a team player with a strong working ethic, time management skill, coordinative ability, and commitment. The successful applicant must have a car for in-state travel. Special Instructions to Applicants:
In order to be considered, you must submit the application, including a resume (GPA must be included), a letter of interest, and a list of references.
Applications must be submitted by 11:55 p.m. (ET) of the posting end date.
This requisition has been reposted. Previous applicants are still under consideration and need not apply.
Health Assessment Required: No
Clinical Research Coord III - Neuro - Multiple Sclerosis
Clinical Research Coordinator Job 37 miles from Ocala
The Department of Neurology, Division of Multiple Sclerosis (MS) is seeking a candidate with a minimum of three years of human subject research experience for a Clinical Research Coordinator III position. This position is responsible for the daily operations of clinical trial studies run by the Multiple Sclerosis Division. The role involves leading clinical trial operations, managing site activities, ensuring compliance with protocols, regulations, and guidelines, and mentoring junior staff. This position will require direct interaction with patients, clinicians, investigators, sponsors, and regulatory bodies at the University of Florida IRB and WCG Copernicus Group. The MS Division is seeking an energetic candidate who is passionate for research and seeks to develop a robust program offering a variety of trials this to this patient population.
About This Role
Responsible for all overall, daily operations of clinical trials run by the Multiple Sclerosis Division. Incumbent will ensure all required regulatory documentation is completed and submitted as appropriate for all research/clinical trial activity which includes, but is not limited to, new submissions, continuing reviews, adverse events, protocol deviations and revisions to the appropriate IRB. Successfully executes multidisciplinary studies, various phased trials (Phase 1-4) research to ensure proper understanding and execution of study protocols. Ensure that all study activities follow Good Clinical Practice (GCP), IRB/ethics guidelines, and regulatory requirements. Job expectations include being present and available to the MS clinic to screen and recruit for studies. Must work well as part of a team and understand the need for flexibility to adapt to changing environments.
In charge of recruiting patients for various studies and responsible for following protocols as outlined, which may include, but is not limited to, screening, administering questionnaires, performing EKGs, obtaining and preparing biological specimens for analysis including blood draws, as well as giving standardized cognitive and motor tests. Enters data into database/source binder/case report forms (CRFs), QAs data to ensure consistency and accuracy, and reports all adverse events.
Corresponds with sponsors and coordinates monitoring visits. Work on other research activities as assigned, and ensures that all research activities are administered appropriately. Promotes and facilitates clinical research for the Department of Neurology in conjunction with the College of Medicine. Provides expertise advice to faculty and department regarding the design of investigator-initiated research. Ensures new investigators, fellows and staff are trained for MS division specific protocols and meet regulatory requirements. Acts as a liaison between study participants, investigators, research staff and sponsors.
Participates in patient, community and health care provider education to include presentations and seminars. Provides and tracks enrollment and attends all weekly research meetings.
About the Neurology - Movement Disorders & Neurorestoration Program:
The University of Florida Health Center for Movement Disorders & Neurorestoration is a nationally recognized hub for patient-centered care and innovation. Guided by the philosophy that integrated, interdisciplinary care is the most effective approach for managing movement disorders and basal ganglia-related conditions, our Center brings together leading specialists to provide comprehensive motor, cognitive, and behavioral diagnoses and treatments-all under one roof.
To learn more about our mission in advancing care, research, and hope for individuals with movement disorders, feel free to visit our website. ***************************************
We Offer Exceptional Benefits:
Low-cost State Health Plans: Medical, Dental, and Vision Insurance
Life and Disability Insurance
Generous Retirement Options to secure your future
Comprehensive Paid Time Off Packages: (includes over 10 paid holidays, as well as paid family, sick and vacation leave)
Exceptional Personal and Professional Development Opportunities: Access to UF Training & Organizational Development programs, leadership development, LinkedIn Learning, and more
Tuition Assistance through the UF Employee Education Program
Public Service Loan Forgiveness (PSLF) Eligible Employer
About Gainesville, Florida:
Home to the University of Florida, one of the nation's top public universities, Gainesville offers vibrant academic and healthcare communities alongside an affordable cost of living, no state income tax, and mild winters. Enjoy the outdoors with over 30 miles of bike trails, freshwater springs, and numerous water activities, plus easy access to beaches and world-class theme parks.
Gainesville combines historic charm with modern amenities, including a great school system, a lively downtown, and a thriving local culture with farmers' markets and craft breweries. Discover professional growth and quality of life in Gainesville-where community, innovation, and work-life balance meet!
For more information, check out: The Guide to Greater Gainesville and Explore Gainesville in 60 seconds
Expected Salary:
61,000 - 68,000 annually
Minimum Requirements:
Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Preferred Qualifications:
The ideal candidate will possess:
3 years or more of human subject research Knowledge of NIH and FDA procedures
Knowledge of state and federal regulations regarding clinical research
Knowledge of accepted procedures and ethical, confidential practices
Proficient in the use of personal computer software, including Microsoft Office
Ability to interpret complex guidelines
Ability to communicate effectively and to meet deadlines as demanded by the position
Certification in a clinical research coordinator course (SOCRA or ACRP)
Special Instructions to Applicants:
To be considered, please upload the following documents with your application:
Cover Letter
Resume
Contact information for three professional references
If an accommodation due to a disability is needed to apply for this position, please call ************ or the Florida Relay System at ************ (TDD).
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: No
Clinical Research Coordinator - Bilingual
Clinical Research Coordinator Job 30 miles from Ocala
Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.
We are actively hiring Bilingual Clinical Research Coordinators at our Leesburg, FL location!
The Clinical Research Coordinator assists the Investigators in executing Phase I, II, III, and IV clinical research trials in accordance with Standard Operating Procedures (SOPs), FDA and GCP guidelines, and study protocols while providing an impeccable patient experience in every, single interaction.
Shift: Monday-Friday, 8 AM - 5:00 PM (occasional weekends)
Compensation: $28/hr - $31/hr + comprehensive benefits, PTO, and 401k match
*paid overtime for weekend work, evening work, or early morning work as needed
RESPONSIBILITIES
The Clinical Research Coordinator (CRC) obtains study participant informed consent.
Executes study protocol procedures in a detailed, organized, and professional manner.
Performs human specimen lab draws and processing, and packages specimen shipments.
Creates and completes study source documents and adverse event reporting on an e-source system.
Maintains study-specific files and supplies.
Communicate with the Study Sponsor/CRO regarding study-specific questions.
Participates in site visits from Sponsors/CROs, including site initiation and monitoring visits.
QUALIFICATIONS
Bachelor's degree preferred, but not required
Experience working neurology studies is a plus, but not required - this site primarily conducts Alzheimer's clinical studies
Phlebotomy experience is required, EKG or other patient labs/processes preferred
Preferably 2+ years of experience as a Clinical Research Coordinator
Familiar with e-source reporting via an electronic platform
A clear understanding of ICH, FDA, and GCP regulations
Impeccable organizational skills and attention to detail
Excellent communication and interpersonal skills to effectively interact with the Principal Investigator, research team, Study Sponsor/CROs, potential subjects, and referral sources
An ethical compass that compels the candidate to be honest, detail-oriented, and self-driven
High-level critical thinking skills
Working knowledge of medical terminology and lab collection/processing/storage procedures
Proficiency with computers and Microsoft Office Suite
Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. Apply today to learn more about how you can join us in our mission to save and improve the lives of others!
Flourish Research is where clinical trials thrive.
Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.
At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality.
Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.
Flourish Research strives to build an organization that attracts and leverages diversity in our staff, which reflects the diversity of our local communities. We promote education, acceptance, and inclusion because there is beauty in diversity. The more diversity we have in our team, the more unique perspectives, and ideas we share, and the better prepared we are to serve our communities. WE SEE YOU. WE ARE YOU. WE EMBRACE YOU. WE CELEBRATE YOU!
It is the policy of Flourish Research not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, or veteran status.
Clinical Coordinator
Clinical Research Coordinator Job 37 miles from Ocala
1971 Salk Ave, Tavares, Florida, 32778-4306, United States of America
DaVita is seeking a Clinical Coordinator who is looking to give life in an outpatient dialysis center. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way - the way you'd want your own care to be?
If you haven't considered Nephrology before, read on as we think that you should.
DaVita - which is Italian for "giving life" - is working to provide quality service to patients, partners, and teammates. Our mission is to be the Provider, Partner, and Employer of Choice.
Some details about this position:
At least 6 months dialysis experience is required.
Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being.
Training may take place in a facility or a training clinic other than your assigned home clinic
Potential to float to various clinics during and after your training
You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays
What you can expect:
Build meaningful and long term relationships with patients and their family in an intimate outpatient setting.
Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians.
Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge.
Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up.
You will work with your head, heart and hands each day in a fast paced environment.
What we'll provide:
DaVita Rewards package connects teammates to what matters most including:
Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
Support for you and your family: family resources, EAP counseling sessions, access Headspace , backup child and elder care, maternity/paternity leave, pet insurance, and more
Paid training
Requirements:
Current Registered Nurse (RN) license in the state of practice
Current CPR certification required
At least 18 months of registered nursing experience
Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required
Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred
Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred
Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree
Current CPR certification required
Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system
Supervisory experience preferred; willingness, desire, and ability to supervise required
Basic computer skills and proficiency in MS Word and Outlook required
DaVita is a clinical leader! We have the highest percentage of facilities meeting or exceeding CMS's standards in the government's two key performance programs. We expect our nurses to commit to improving patient health through clinical goal setting and quality improvement initiatives.
Ready to make a difference in the lives of patients? Take the first step and apply now.
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
This position will be open for a minimum of three days.
Salary/ Wage Range
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************
Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.
Clinical Coordinator
Clinical Research Coordinator Job 37 miles from Ocala
1971 Salk Ave, Tavares, Florida, 32778-4306, United States of America DaVita is seeking a Clinical Coordinator who is looking to give life in an outpatient dialysis center. You can make an exceptional difference in the lives of our patients and their families dealing with end-stage renal failure or chronic kidney disease. Do you desire to deliver care in an empathetic, compassionate way - the way you'd want your own care to be?
If you haven't considered Nephrology before, read on as we think that you should.
DaVita - which is Italian for "giving life" - is working to provide quality service to patients, partners, and teammates. Our mission is to be the Provider, Partner, and Employer of Choice.
Some details about this position:
* At least 6 months dialysis experience is required.
* Coordinate ESRD patient care and services (trend lab values, track metrics on vital signs, weight, outcome management, etc.)• Ensure you and your clinical team are delivering the highest level of care to our patients by ensuring their safety, comfort, and well-being.
* Training may take place in a facility or a training clinic other than your assigned home clinic
* Potential to float to various clinics during and after your training
* You must have a flexible schedule and be able to work mornings, evenings, weekends, and holidays
What you can expect:
* Build meaningful and long term relationships with patients and their family in an intimate outpatient setting.
* Be a part of a team that supports and relies on each other in a positive environment. Staff RNs are a central part of a small interdisciplinary team of clinicians.
* Deliver care to patients who are often dealing with multiple co-morbidities which require unique treatment plans and the ability to leverage a broad range of nursing skills and knowledge.
* Oversee a group of patients with the support of PCTs to conduct patient observations, measuring stats and machine set up.
* You will work with your head, heart and hands each day in a fast paced environment.
What we'll provide:
DaVita Rewards package connects teammates to what matters most including:
* Comprehensive benefits: Medical, dental, vision, 401(k) match, paid time off, PTO cash out
* Support for you and your family: family resources, EAP counseling sessions, access Headspace, backup child and elder care, maternity/paternity leave, pet insurance, and more
* Paid training
Requirements:
* Current Registered Nurse (RN) license in the state of practice
* Current CPR certification required
* At least 18 months of registered nursing experience
* Dialysis Charge RN readiness approval by Clinical Nurse Manager or RN-licensed FA/GFA required
* Certified Nephrology Nurse (CNN) or Certified Dialysis Nurse (CDN) preferred
* Intensive Care Unit (ICU), Critical Care Unit (CCU), Emergency Room (ER), or Medical Surgical (Med Surg) experience is preferred
* Associates Degree in Nursing (A.D.N) from accredited school of nursing required; Bachelor of Science in Nursing (B.S.N) preferred; three-year diploma from accredited diploma program may be substituted for nursing degree
* Current CPR certification required
* Completed training approved by the medical director and the governing body as required by CMS guidelines prior to operating the water treatment system
* Supervisory experience preferred; willingness, desire, and ability to supervise required
* Basic computer skills and proficiency in MS Word and Outlook required
DaVita is a clinical leader! We have the highest percentage of facilities meeting or exceeding CMS's standards in the government's two key performance programs. We expect our nurses to commit to improving patient health through clinical goal setting and quality improvement initiatives.
Ready to make a difference in the lives of patients? Take the first step and apply now.
At DaVita, we strive to be a community first and a company second. We want all teammates to experience DaVita as "a place where I belong." Our goal is to embed belonging into everything we do in our Village, so that it becomes part of who we are. We are proud to be an equal opportunity workplace and an affirmative action employer. As such, individuals are recruited, hired, assigned and promoted without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, protected veteran status, or any other protected characteristic.
This position will be open for a minimum of three days.
Salary/ Wage Range
Compensation for the role will depend on a number of factors, including a candidate's qualifications, skills, competencies and experience and may fall outside of the range shown. DaVita offers a competitive total rewards package, which includes a 401k match, healthcare coverage and a broad range of other benefits. Learn more at ***********************************
Colorado Residents: Please do not respond to any questions in this initial application that may seek age-identifying information such as age, date of birth, or dates of school attendance or graduation. You may also redact this information from any materials you submit during the application process. You will not be penalized for redacting or removing this information.
Sr. Clinical Research Scientist
Clinical Research Coordinator Job 43 miles from Ocala
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you'll love working at Axogen:
Friendly, open, and fun team culture that values unique perspectives
Company-wide dedication to profoundly impacting patients' lives
Comprehensive, high-quality benefits package effective on date of hire
Educational assistance available for all employees
Matching 401(k) retirement plan
Paid holidays, including floating holidays, to be used at your discretion
Employee Stock Purchase Plan
Referral incentive program
If you want to see how you can impact lives at Axogen, take a look at these inspiring patient stories: ******************************************
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Sr. Clinical Research Scientist
The Sr. Clinical Research Scientist will play a critical role in leading and managing clinical research activities, with a focus on advancing peripheral nerve science and its clinical applications. This position requires expertise in clinical trial design, data analysis, and regulatory submissions, ideally within the biotech or medical device industries. The successful candidate will collaborate cross-functionally to drive the development and execution of clinical strategies that support product efficacy, safety, and regulatory compliance.
Requirements of the Sr. Clinical Research Scientist
Advanced degree (PhD, PharmD, MD) in life sciences, clinical research, biomedical engineering or a related field.
Minimum 5 years of experience in clinical research in the biotech or medical device industry, including experience in leading clinical trials.
In-depth knowledge of clinical trial design, regulatory requirements, and GCP.
Experience with FDA submissions, including INDs, BLAs, PMAs, and/or 510(k)s.
Strong leadership skills with the ability to work in cross-functional teams.
Excellent written and verbal communication skills, including the ability to present complex clinical data to both scientific and non-scientific audiences.
Responsibilities of the Sr. Clinical Research Scientist
The specific duties of the Sr. Clinical Research Scientist include but are not limited to:
Clinical Study Design and Protocol Development:
Lead the design and development of clinical study protocols, including objectives, endpoints, sample size determination, and statistical analysis plans.
Collaborate with cross-functional teams (regulatory, R&D, biostatistics, etc.) to align study design with regulatory strategies and product development goals.
Contribute to the development of clinical strategies to support product claims and marketing.
Clinical Study Execution:
Oversee the execution of clinical studies, ensuring compliance with Good Clinical Practice (GCP), relevant regulations, and company standards.
Provide scientific oversight and ensure clinical data integrity and quality throughout the study.
Manage relationships with key opinion leaders (KOLs), investigators, and clinical research organizations (CROs).
Data Analysis and Interpretation:
Collaborate with biostatistics and data management teams to ensure accurate data analysis and reporting.
Interpret clinical study results and generate clinical study reports, publications, and presentations.
Provide scientific input on interim analyses, final analyses, and any safety-related issues that arise during the trial.
Cross-Functional Collaboration:
Work closely with R&D, regulatory affairs, quality, and commercial teams to ensure clinical program alignment with business objectives.
Participate in project team meetings and provide clinical updates and scientific insights.
Support product development by integrating clinical evidence into product design, development, and labeling.
Scientific Communication and Publications:
Develop and deliver scientific presentations at industry conferences, advisory boards, and internal meetings.
Lead the preparation and submission of manuscripts for peer-reviewed journals, contributing to the company's scientific reputation.
Compliance and Risk Management:
Ensure compliance with all relevant clinical research guidelines, ethical standards, and regulatory requirements.
Identify and mitigate risks related to clinical trial conduct, including patient safety, data integrity, and operational challenges.
Innovation and Continuous Improvement:
Stay updated on the latest trends, technologies, and methodologies in clinical research and the therapeutic area of focus.
Drive process improvements in clinical operations, study design, and data management practices.
Location
13631 Progress Blvd., Alachua, FL 32615
OR
111 West Oak Ave., Tampa, FL 33602
OR
Remote
#LI-AC1
#LI-REMOTE
Benefits/Compensation
This position is eligible for an annual bonus. Benefits offered for this position include Health, Dental, Vision, Matching 401K, Paid Time Off, 9 Paid Holidays + 3 Floating Holidays, Dependent Care Flexible Spending Accounts, Medical Flexible Spending Accounts, Tuition Reimbursement, Paid Parental Leave, Paid Caregiver Leave, Basic Life Insurance, Supplemental Life Insurance, Employee Stock Purchase Plan, and Disability Insurance, as described in more detail in summary plan descriptions.
Salary Range$122,386—$152,982 USD
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
Clinical Research Site Manager
Clinical Research Coordinator Job In Ocala, FL
is incentive eligible. Introduction Are you passionate about the patient experience? At HCA Healthcare, we are committed to caring for patients with purpose and integrity. We care like family! Jump-start your career as a Clinical Research Site Manager today with HCA Florida Ocala Hospital.
Benefits
HCA Florida Ocala Hospital, offers a total rewards package that supports the health, life, career and retirement of our colleagues. The available plans and programs include:
* Comprehensive medical coverage that covers many common services at no cost or for a low copay. Plans include prescription drug and behavioral health coverage as well as free telemedicine services and free AirMed medical transportation.
* Additional options for dental and vision benefits, life and disability coverage, flexible spending accounts, supplemental health protection plans (accident, critical illness, hospital indemnity), auto and home insurance, identity theft protection, legal counseling, long-term care coverage, moving assistance, pet insurance and more.
* Free counseling services and resources for emotional, physical and financial wellbeing
* 401(k) Plan with a 100% match on 3% to 9% of pay (based on years of service)
* Employee Stock Purchase Plan with 10% off HCA Healthcare stock
* Family support through fertility and family building benefits with Progyny and adoption assistance.
* Referral services for child, elder and pet care, home and auto repair, event planning and more
* Consumer discounts through Abenity and Consumer Discounts
* Retirement readiness, rollover assistance services and preferred banking partnerships
* Education assistance (tuition, student loan, certification support, dependent scholarships)
* Colleague recognition program
* Time Away From Work Program (paid time off, paid family leave, long- and short-term disability coverage and leaves of absence)
* Employee Health Assistance Fund that offers free employee-only coverage to full-time and part-time colleagues based on income.
Learn more about Employee Benefits
Note: Eligibility for benefits may vary by location.
Come join our team as a Clinical Research Site Manager. We care for our community! Just last year, HCA Healthcare and our colleagues donated 13.8 million dollars to charitable organizations. Apply Today!
Job Summary and Qualifications
The Site Manager is responsible for the overall clinical operations and management of a specified HCA Research Institute site and its affiliated physician groups. The Site Manager serves as a liaison with local investigators, hospital administration, and local research personnel.
Duties include but are not limited to:
Research Operations Management
* Practices and adheres to the "Code of Conduct" philosophy and "Mission and Value Statement"
* Oversee and manage routine operational activities of HRI site research staff
* Liaise between site research personnel, industry sponsors, and HRI Division Director/leadership
* Collaborate closely with various site departments/teams, including finance, relevant hospital administrative representatives, and the local IRB, if applicable
* Review proposed budgets for adequate coverage and recommends changes to Supervisor
* Facilitate contracting with hospitals, provider groups, and/or vendors, as needed
* Engage with revenue integrity to assist with reconciling study payments at the site
* Actively engage in tracking of studies conducted at the site
* Oversee study progress at the site from initial submission of feasibility until study closeout
* Coordinate submission and approval for the Site's Facility Review Committee, if applicable
* Manage HRI site team responsible for coordinating multiple research studies across several therapeutic areas
Site development:
* Work with site personnel, local investigators, and hospital administration to assess site feasibility and resourcing for existing and upcoming research protocols
* Assist in development and tracking of quarterly site goals
* Regularly meet with physicians and administrators to assess site performance and investigator satisfaction
* Provide a research update during Site Administrative meetings (Section meetings, Site Service Line meetings, etc.)
Reporting and Analysis:
* Monitor patient enrollment at the site through weekly reports, and reports results to Supervisor
* Communicate site status and site development through a monthly activity report
* Facilitate continuing education and training to investigators and site research team members
* Evaluate operational metrics to continuously improve study quality and/or improve processes
* Complete performance evaluations for direct reports
Education/Experience:
* Bachelor's Degree required; Master's Degree preferred
* 5+ years of experience in healthcare, research, or other science related field
* Complete performance evaluations for direct reports
Licenses, Certifications, & Training:
* Research Certification (ACRP or CCRP) required
"The great hospitals will always put the patient and the patients family first, and the really great institutions will provide care with warmth, compassion, and dignity for the individual."- Dr. Thomas Frist, Sr.
HCA Healthcare Co-Founder
If you are looking for an opportunity that provides satisfaction and personal growth, we encourage you to apply for our Clinical Research Site Manager opening. We promptly review all applications. Highly qualified candidates will be contacted for interviews. Unlock the possibilities and apply today!
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
Clinical Research Coordinator III
Clinical Research Coordinator Job 37 miles from Ocala
The Clinical Research Coordinator will have various responsibilities related to: Preparation and/or Review of the Scientific Proposal, Regulatory and IRB Protocols, Sponsor Contract (Terms & Conditions), Conduct of Research, Clinical Services; Research Associate and other Staff Management, Reporting, and Project Closeout procedures.
Research Coordinator II
Clinical Research Coordinator Job 37 miles from Ocala
Support the development of planning for the study, implementation, and manage day-to-day operations of research programs. Translate planning and design decisions into concrete activities and tasks, assign these tasks, and set priorities for their implementation. Ensure proper communication among stakeholders, staff, study sponsors, and investigators, to coordinate the assigned directives and accomplish deliverables. The work includes monitoring and coordinating research project operations, including project plans, timelines, and tasks. Assist in working with and monitoring the progress of work conducted by external vendors and subcontractors. Experience working with interdisciplinary teams in both academic and professional environments.
Develop project/work plan. Monitor progress, identify and resolve barriers to progress, and work with project leadership to make any necessary adjustments to scope, timeline, and/or budget. Communicate with faculty and staff, sponsors, community partners, and other external constituencies as needed. Coordinating data collection activities including conducting interviews; coordinating survey printing, online survey creation, and distribution; creating and maintaining project timelines; facilitating participating site intervention activities and maintaining contact with sites; recruiting research participants; and coordinating with electronic health records (EHR) and information technology (IT) development staff.
Responsible for preparation of reports, manuscripts, and grant proposals including performing literature searches, creating cohesive literature summaries, creating figures, formatting references, and creating budget justifications.
Maintaining project compliance with regulations including creating and renewing IRB protocols, serving as custodian for human subjects' payments, and managing budgets.
Oversight of students and staff, ensuring that daily tasks are completed, and project timelines are communicated across the team and met.
Expected Salary:
$55,000.00 - $65,000.00
Minimum Requirements:
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Preferred Qualifications:
Master's degree in Social/Behavioral Sciences, Public Health, Gerontology, Health Services Research, or related fields.
* Experience in older adult health outcomes/health services research and data management.
* Ability to work independently with minimal supervision. Excellent written and oral communication skills.
* Ability to manage multiple projects simultaneously.
* Attention to detail, particularly with regard to data accuracy and integrity.
* Strong computer skills (MS Office, including Word, Excel, and PowerPoint).
* Good working knowledge of data analysis software (e.g., SAS, SPSS or Qualtrics).
* Ability to interpret basic statistical results.
* Experience working with large research projects and with older adults.
Special Instructions to Applicants:
The University of Florida is committed to non-discrimination with respect to race, creed, color, religion, age, disability, sex, sexual orientation, gender identity and expression, marital status, national origin, political opinions or affiliations, genetic information and veteran status in all aspects of employment including recruitment, hiring, promotions, transfers, discipline, terminations, wage and salary administration, benefits, and training.
In order to be considered, you must upload your cover letter and resume.
This requisition has been reposted. Previous applicants are still under consideration and need not apply.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: No.
Research Coordinator II
Clinical Research Coordinator Job 37 miles from Ocala
The Department of Psychiatry is seeking a dedicated and detail-oriented Research Coordinator II to support our ongoing research studies. This position plays a critical role in participant recruitment, data collection, project coordination, and lab personnel oversight. The ideal candidate will have experience in clinical research, data management, and working collaboratively in a research setting.
Participant Recruitment & Data Collection
* Lead participant recruitment and coordinate study design.
* Conduct consenting processes and collect biological samples (blood and saliva).
* Schedule participants and assist in electrophysiological protocols, neuropsychological testing, and MRI procedures.
* Maintain communication with potential participants regarding eligibility and study participation.
* Train research staff, undergraduate researchers, graduate students, and post-doctoral associates on study procedures.
Data Management
* Ensure data integrity, scoring, and entry across multiple databases, including MS Access, REDCap, and Excel.
* Maintain historical research databases and manage hard-copy research files.
* Assist in developing new data entry forms and ensure compliance with research protocols.
Project Coordination & Compliance
* Monitor study timelines, IRB renewals, and participant payment processes.
* Collaborate with research staff to maintain recruitment goals, data quality, IRB compliance, and online instrument functionality.
* Oversee volunteer onboarding, training, and task completion.
Expected Salary:
$50,000 - $60,000; commensurate with education and experience.
Minimum Requirements:
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Preferred Qualifications:
* Bachelor's or master's degree in psychology, Neuroscience, or a related field preferred.
* Experience in clinical research, participant recruitment, and data management.
* Proficiency in MS Access, REDCap, and Excel is a plus.
* Strong organizational and communication skills.
* Ability to multitask and work collaboratively in a fast-paced research environment.
Special Instructions to Applicants:
In order to be considered, you must upload your cover letter, resume and list of three professional reference with contact information.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: No
Research Coordinator I
Clinical Research Coordinator Job 37 miles from Ocala
Research/Grant: Support the FDOT ride specifications project through the certification of inertial profilers used to evaluate smoothness on FDOT projects. Activity will include development of procedures and documentation for certifying of inertial profilers, monitoring of test track ride quality, and creation of the implementation plan for the inertial profiler certification program. Compiles information, assists with future grant proposals and works with project PI and the MAE Award Offices to ensure correct proposal submission and post award administration. Pre Award team will submit proposals and all Post Award actions will be undertaken by Post Award team but the individual will liaise with the PI and the Research Admin team for confirmation on increments, status of progress reports, technical and final reports, and justification for budget approvals on PI's behalf. Project expenditure on the grants and making sure that they are consistent with the budget of the grant on regular basis. Although primary research will be performed at UF, (Gainesville, FL), field work will be conducted at the Williston Airport.
Clerical:
Prepare, edit and submit various reports, arrange and schedule various meetings. May be required to compile and prepare correspondence as directed; prepare PowerPoint presentations, Microsoft Word documents, technical writings, spreadsheets, graphs, charts and tables under PI direction. Confirm effort and coordinate certification of effort with PI.
Fiscal:
Coordinate travel functions; make arrangements, generate Travel Authorization Requests and reimbursements through the online MAE Webpage for research members in keeping with UF Travel Policies and Procedures; provide information needed for purchase requisitions or use Purchasing Card to order supplies for the project, responsible for shipping of various samples and supplies as deemed appropriate. Provide receipts and backup needed and verify Chatfield for departmental administrative office reconciliation.
Asset Management:
Track and maintain asset records for purchases associated with related projects through coordination with Departmental Asset Manager.
Other related duties as deemed appropriate.
Research Coordinator III
Clinical Research Coordinator Job 37 miles from Ocala
Responsible for the coordination of research, outreach, and education projects associated with the Center for Remote Sensing (CRS). This position will work closely with the Director in developing partnerships among the Center Affiliate Faculty, identifying funding opportunities for remote sensing related projects, and developing and implementing outreach components to foster and coordinate partnerships with K-12 teachers, industry, media, state & local government agencies, and international partners.
Plays a critical role in supporting the mission of the center, ensuring the successful implementation of research projects, outreach activities, and communication of educational initiatives.
Research Coordinator III
Clinical Research Coordinator Job 37 miles from Ocala
Responsible for the coordination of research, outreach, and education projects associated with the Center for Remote Sensing (CRS). This position will work closely with the Director in developing partnerships among the Center Affiliate Faculty, identifying funding opportunities for remote sensing related projects, and developing and implementing outreach components to foster and coordinate partnerships with K-12 teachers, industry, media, state & local government agencies, and international partners. Plays a critical role in supporting the mission of the center, ensuring the successful implementation of research projects, outreach activities, and communication of educational initiatives.
Research Coordination: Coordinate research projects with Affiliate Faculty, including proposal writing and submission, ensuring timely and effective management of the research process. Collaborate with the Director to monitor progress on research goals and projects, providing regular updates and recommendations for improvement. Prepare research briefs and white papers for dissemination, highlighting the research team's achievements and contributions to the field. Facilitate research/project team meetings, contributing to problem-solving and decision-making processes. Assess protocol and audits studies, ensuring adherence to university and regulatory standards.
Outreach and Education: Coordinate educational activities, including the development of curriculum materials for K-12 and general audiences in remote sensing, aligning with industry and educational standards. Develop and oversee implementation of outreach components to foster partnerships with K-12 teachers, industry, media, state & local government agencies, and international partners, promoting collaborative research and knowledge transfer. Collaborates with the Director in developing statewide and international partnerships with public and private sectors, ensuring strategic engagement and collaboration.
Communication: Update and maintain website content, ensuring accurate and current information about research activities, outreach initiatives, and educational programs. Develop and disseminate outreach materials to Center audiences, utilizing various communication channels and platforms. Serve as a contact to media outlets to maximize communication of research areas to the general public, ensuring accurate and timely representation of the Center's work. Work closely with collaborators, UF News bureau, College communicators, etc. to facilitate communication activities, promoting knowledge transfer and research impact. Develop and analyze metrics to evaluate the effectiveness of outreach and communication activities, making data-driven decisions to improve results.
Other: Maintain Center space and equipment inventory
Expected Salary:
Commensurate with Education and Experience
Minimum Requirements:
Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.
Preferred Qualifications:
Bachelor's degree with at least three years of experience or a Master's degree with at least two years of experience.
Incumbent must be detail-oriented and well-organized, able to manage a variety of tasks, and sensitive to the needs of stakeholders and UF faculty with research, extension, and teaching. Incumbent must be able to use good judgment with regard to time management, and able to administer and coordinate projects and proposals effectively and efficiently.
Special Instructions to Applicants:
In order to be considered, you must upload your cover letter, resume and three professional references."
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
This requisition has been reposted. Previous applicants are still under consideration and need not reapply.
Health Assessment Required: No