Clinical Research Associate I (Per Diem) - Smidt Heart Institute
Clinical Research Coordinator Job 50 miles from Laguna Hills
The Smidt Heart Institute reflects Cedars-Sinai's steadfast dedication to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and niche care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to a growing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Join our team and use your skills with an organization known nationally for excellence in research!
The Clinical Research Associate I works directly with a Clinical Research Coordinator, Research Program Administrator, or Research Nurse to coordinate and/or implement the study. Evaluates and abstracts research data and ensures compliance with protocol and research objectives. Responsible for completing case report forms, entering clinical research data, and assist with regulatory submissions to the IRB. Provides limited patient contact as needed for study and assist with study budget and patient research billing. Ensures compliance with all federal, local, FDA, IRB, and HIPAA guidelines and regulations pertaining to the study and patient care.
Primary Duties and Responsibilities
Works with a Clinical Research Coordinator, Research Program Administrator or Research Nurse to coordinate/implement study.
Evaluates and abstracts clinical research data from source documents.
Ensures compliance with protocol and overall clinical research objectives.
Completes Case Report Forms (CRFs).
Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
Provides supervised patient contact or patient contact for long term follow-up patients only.
Assists with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
Assists with clinical trial budgets.
Assists with patient research billing.
Schedules patients for research visits and research procedures.
Responsible for sample preparation and shipping and maintenance of study supplies and kits.
Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
Maintains research practices using Good Clinical Practice (GCP) guidelines.
Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
Participates in required training and education programs.
Qualifications
Education
Highschool diploma/GED required
Bachelor's Degree in Science, Sociology or related degree preferred
Experience
1-year Clinical Research Related Experience
About UsCedars-Sinai is a leader in providing high-quality healthcare encompassing primary care, specialized medicine and research. Since 1902, Cedars-Sinai has evolved to meet the needs of one of the most diverse regions in the nation, setting standards in quality and innovative patient care, research, teaching and community service. Today, Cedars- Sinai is known for its national leadership in transforming healthcare for the benefit of patients. Cedars-Sinai impacts the future of healthcare by developing new approaches to treatment and educating tomorrow's health professionals. Additionally, Cedars-Sinai demonstrates a commitment to the community through programs that improve the health of its most vulnerable residents.
About the TeamCedars-Sinai is one of the largest nonprofit academic medical centers in the U.S., with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Choose this if you want to work in a fast-paced environment that offers the highest level of care to people in the Los Angeles that need our care the most.
Req ID : 5158
Working Title : Clinical Research Associate I (Per Diem) - Smidt Heart Institute
Department : Heart Institute
Business Entity : Cedars-Sinai Medical Center
Job Category : Academic / Research
Job Specialty : Research Studies/ Clin Trial
Overtime Status : NONEXEMPT
Primary Shift : Day
Shift Duration : 8 hour
Base Pay : $19.50 - $32.86
Travel Clinical Research Coordinator - $1,961 per week
Clinical Research Coordinator Job 50 miles from Laguna Hills
PRIDE Health is seeking a travel Clinical Research Coordinator for a travel job in Los Angeles, California.
Job Description & Requirements
Specialty: Clinical Research Coordinator
Discipline: Allied Health Professional
Start Date: 04/07/2025
Duration: 13 weeks
40 hours per week
Shift: 8 hours, days
Employment Type: Travel
Pride Health Job ID #16108617. Pay package is based on 8 hour shifts and 40.0 hours per week (subject to confirmation) with tax-free stipend amount to be determined. Posted job title: Clinical Research:Clinical Research Coordinator,09:00:00-17:00:00
About PRIDE Health
PRIDE Health is the minority-owned healthcare recruitment division of Pride Global-an integrated human capital solutions and advisory firm. With our robust and abundant travel nursing and allied health employment options across the U.S., PRIDE Health will allow you to help change the way the world lives and heals as it connects you with the industry's leading healthcare organizations.
Pride Global offers eligible employee's comprehensive healthcare coverage (medical, dental, and vision plans), supplemental coverage (accident insurance, critical illness insurance and hospital indemnity), 401(k)-retirement savings, life & disability insurance, an employee assistance program, legal support, auto, home insurance, pet insurance, and employee discounts with preferred vendors.
Benefits
Weekly pay
Holiday Pay
Guaranteed Hours
401k retirement plan
Cancelation protection
Referral bonus
Medical benefits
Dental benefits
Vision benefits
Clinical Trial Manager
Clinical Research Coordinator Job 7 miles from Laguna Hills
Clinical Trial Manager (Level TBD Based on Experience)
Salary: $120,000-$160,000
· If you reside in California: Full-time employment with medical may be offered.
· Outside California: Must be a contractor.
About the Role
We are seeking a self-motivated, results-driven Clinical Trial Manager (CTM) to join our Clinical Operations (ClinOps) team. The CTM plays a critical role in ensuring the successful execution of clinical trials by managing study operations, vendors, and site activities. This individual must be able to work independently, take initiative, and require minimal supervision or reminders to keep studies on track.
The CTM will be responsible for overseeing clinical trials from study startup to closeout, ensuring compliance with Good Clinical Practice (GCP), FDA, EMA, and ICH regulations, as well as internal and vendor Standard Operating Procedures (SOPs).
How the CTM Fits Within Clinical Operations
The CTM is a core function within the Clinical Operations team, responsible for ensuring that assigned clinical trials are executed on time, within budget, and in compliance with all regulatory requirements. This role involves:
Study Execution & Oversight - Managing trial activities and ensuring operational success.
Vendor & CRO Management - Overseeing CROs, central labs, and other clinical vendors to align with study objectives.
Site & Investigator Oversight - Working closely with clinical sites and investigators to ensure patient enrollment and protocol adherence.
Risk Management & Issue Resolution - Identifying challenges, escalating when necessary, and implementing solutions.
TMF & Compliance - Ensuring all essential documents are maintained in the Trial Master File (TMF) per regulatory requirements.
Technology & Systems Management - Managing and utilizing clinical trial technologies to enhance efficiency and data integrity.
Cross-Functional Collaboration - Working with internal and Vendor-Regulatory, Data Management, Medical Monitoring, and Safety teams to ensure smooth trial execution.
Key Responsibilities
Oversee clinical trial execution from study startup through closeout in alignment with business goals.
Manage CROs, central labs, and other study vendors to ensure study timelines, quality, and compliance are met.
Ensure adherence to SOPs, FDA regulations, ICH/GCP guidelines, and other relevant regulatory requirements.
Review and contribute to study-specific documentation, including protocols, informed consent forms, case report forms, and study manuals.
Monitor study progress by reviewing site monitoring reports, tracking enrollment, and ensuring compliance at clinical sites.
Lead study management team meetings, track action items, and drive accountability among cross-functional teams.
Identify, escalate, and resolve study-related issues while maintaining proactive communication.
Conduct in-person or remote site visits (e.g., training, site initiation, monitoring visits) as needed.
Ensure proper documentation and compliance within the Trial Master File (TMF).
Technology & System Requirements
The ideal candidate should be highly proficient with technology and have a higher-than-average level of experience using the following:
Microsoft Office Suite - Excel, Word, PowerPoint, Outlook (including advanced Excel functionalities such as pivot tables, VLOOKUP, and data analysis).
Project & Workflow Management Tools - Smartsheet, Monday.com
Electronic Data Capture (EDC) Systems - e.g., Medidata Rave
Electronic Trial Master File (eTMF) Systems - e.g., Veeva Vault, Trial Interactive, or similar.
Document Management Systems (DMS) - e.g., SharePoint, or similar.
Virtual Meeting & Collaboration Tools - Must be comfortable being on video for remote meetings via Microsoft Teams, and other communication tools.
Qualifications
BA/BS degree required with at least 6 years of industry experience in clinical operations within the biopharmaceutical industry, 3 of those years can be in a CRO ClinOps department.
Experience managing Phase 1 Cell Therapy Autologous clinical studies that rely on clinical outsourcing.
Ability to work independently, take ownership of assigned studies, and execute tasks without requiring excessive supervision or reminders.
Strong organizational, analytical, and problem-solving skills with the ability to manage multiple priorities and anticipate challenges.
Experience leading and collaborating with internal and external teams, including CROs, vendors, and consultants.
Strong communication and influencing skills with the ability to drive team alignment and accountability.
In-depth knowledge of FDA, EMA, ICH, and GCP regulations and guidelines.
Comfortable in a fast-paced, small-company environment and able to adjust workload based on shifting priorities.
Comfortable reporting to Director of Clinical Program or Chief Operating Officer.
Ability to travel (~15%) as required for program needs.
Senior Clinical Research Specialist
Clinical Research Coordinator Job 7 miles from Laguna Hills
Kelly Science and Clinical FSP is currently seeking a Senior Clinical Research Specialist for a long-term engagement in Irvine, CA with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Summary:
This Senior Clinical Research Specialist will be responsible for supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Responsibilities:
Serves as a Senior Clinical Research Specialist within the Clinical R&D Department to support execution of company sponsored clinical trials, ensuring compliance with timelines and study milestones, for
Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures
May serve as the primary contact for clinical trial sites (e.g. site management)
Contributes towards development of clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports)
Supports applicable trial registration (e.g. *********************** from study initiation through posting of results and support publications as needed
Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
Interfaces, collaborates and oversees Clinical Research Associates (CRAs)
Oversees and supports the development and execution of Investigator agreements and trial payments
Is responsible for clinical data review to prepare data for statistical analyses and publications
May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need
May contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS) within the assigned projects
May provide on-site procedural protocol compliance and data collection support to the clinical trial sites
Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated
Contributes to delivery of assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);
May development of e Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER) within the defined timelines and review/update at planned intervals; May assist with maintaining the overview to assure (study) commitments are timely and properly met by coordination of specific documentation and contribution to cross-functional review of associated documents where relevant
Supports project/study budget activities
Mentors team members
May perform other duties assigned as needed
Is responsible for communicating business related issues or opportunities to next management level. Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders
Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures
Should develop a strong understanding of the pipeline, product portfolio and business needs
Generally manages work with supervision, dependent on project complexity. Independent decision-making for simple and more advanced situations but requires guidance for complex situations.
Experience & Education:
Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
BS with at least 4 years
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV)
Clinical/medical background is a plus.
Medical device experience
Cardiovascular experience
Clinical Research Associate (CRA) II/Senior CRA
Clinical Research Coordinator Job 50 miles from Laguna Hills
Job Title: Clinical Research Associate (CRA) II/Senior CRA
Job Type: Permanent Full Time
Must Have: Minimum 2 Years of On Site Monitoring Experience & 1 Year of Oncology Experience
Our client is a global leader in healthcare data, technology, and advanced analytics, dedicated to supporting the pharmaceutical and biotechnology industries in the development of ground-breaking treatments. With a strong focus on oncology, our mission is to accelerate the discovery and development of life-changing therapies. They are seeking a highly skilled Clinical Research Associate II (CRA II) to join our team and contribute to the success of cutting-edge oncology clinical trials.
Key Responsibilities:
Oversee and manage the progress of clinical trials at investigational sites, ensuring adherence to the study protocol, ICH-GCP, and local regulatory requirements.
Conduct site initiation, monitoring, and close-out visits, offering continuous support to ensure optimal site performance.
Establish and maintain strong working relationships with investigators, site staff, and other key stakeholders.
Ensure accurate and timely collection and reporting of clinical trial data.
Proactively identify potential risks and work with the study team to resolve issues affecting timelines, data quality, or compliance.
Provide guidance to junior CRAs and assist in their professional development.
Ensure all clinical trial documentation is maintained in compliance with regulatory requirements and company SOPs.
Regional travel.
Qualifications:
A minimum of 2 years of experience as a Clinical Research Associate (CRA) in a clinical research environment.
At least 1 year of experience in oncology clinical trials, with a solid understanding of oncology treatment modalities and protocols.
In-depth knowledge of ICH-GCP, FDA, and other regulatory standards and guidelines.
Excellent organizational, communication, and problem-solving skills.
Ability to travel to clinical sites as required by the study.
A bachelor's degree in Life Sciences or a related field (or equivalent experience).
CRA certification (e.g., ACRP or SOCRA) preferred but not required.
If you are interested in finding out more about this role or others, please contact Sharleney Chandraratna at *********************************** or call: +44 (0) **********
Research Coordinator: Big Law Partner Recruiting Agency
Clinical Research Coordinator Job 50 miles from Laguna Hills
Prestigious Agency focuses on law firm partner level recruiting seeks an outstanding candidate to head up the Research Coordinator division.
Our clients are predominantly Top 20 Global law firms, and the best individual partners and groups who work at these firms. Our markets are all over the world including major US markets, London, Asia, the Middle East and key European cities.
You will work with the Research & Marketing team to identify and curate comprehensive lists of potential lawyer partners, practice groups, and legal professionals for specific client needs. You will maintain and update our extensive database with accurate and relevant information and ensure data integrity and consistency for effective outreach each day. Target lists will be compiled based on our clients' hiring needs. In addition, you will conduct in-depth market research to identify trends, emerging law firms, and potential growth areas and provide insights to the team for strategic decision-making.
This is a fast-paced role that requires constant attention, close attention to trends, and a high degree of meticulousness. In the end, we are looking for someone who always wants to better their work and hold themselves to a standard that matches our law firm clients' needs.
We are a leading agency worldwide and known for our prolific email marketing campaigns at the highest levels of the BIGLAW community. You will learn more about law and business more than most any job. Earning potential is limitless.
*You will also collaborate closely with the CEO, especially when she receives specific partner requests from the firms we work with.
Ideal Candidate:
1) Positive, strategic, and detail-oriented
2) Quick learner with the ability to adapt
3) Extremely persistent and focused
Recent college graduates with an interest in law are encouraged to apply.
Requirements:
Bachelor's degree from a reputable 4-year college
Typing Speed 65+ WPM
Highly accurate spelling and grammar.
Meticulous about accuracy, incredibly organized, and likes structure.
Proficient in computer usage and database management.
Openness to constructive feedback and a drive to improve one's work.
Demonstrates a strong work ethic, including reliable attendance, and is collaborative in a team environment.
A TEAM leader!
Compensation & Benefits:
Hourly Pay - $26-28/hr
*Please note overtime is regularly available (time & a half) and, on occasion, required.
Job Type: Full-time, Weekends as needed
Schedule: Monday to Friday, 9 AM - 5:30 PM
Location: In Person at the Westwood Office in Los Angeles, CA 90067- must be able to reliably commute or planning to relocate before starting work.
Benefits:
Health insurance
401K
Academic/Faculty/Research Nurse Practitioner
Clinical Research Coordinator Job 38 miles from Laguna Hills
Colton, CA - Seeking Population Health Nurse Practitioner
Become a Valued Member of Your Population Health Team
As an Advanced Provider, you play a critical role in our mission to improve lives in Population Health and are a valued member of the full care team. At Vituity we know the impact you can have.
Join the Vituity Team. At Vituity we've cultivated an environment where passion thrives, and success comes through shared purpose. We were founded in a culture that values team accomplishments more than individual achievements, an approach we call "culture of brilliance." Together, we leverage our strengths and experiences to make a positive impact in our local communities. We foster this through shared goals and helping our colleagues succeed, and we also understand the importance of recognition, taking the time to show appreciation and gratitude for a job well done.
Vituity Locations: Vituity has opportunities at 475 sites across the country, serving 9 million patients a year. With Vituity, if you ever need to move, you can take your job with you.
The Opportunity
Vituity at Arrowhead Regional Medical Center (ARMC) is seeking an experienced and dedicated Population Health Nurse Practitioner to support our value-based care initiatives and improve health outcomes for our patients.
This role involves providing direct patient care, supporting primary care clinicians in quality improvement efforts, and educating community clinicians on best practices for closing care gaps.
Opportunity to make a meaningful impact in population health and quality care initiatives.
Clinical Support & Care Coordination
Provide in-basket support to primary care clinicians regarding quality measures, lab results, and registries.
Collaborate with the ARMC Value-Based Program team on quality initiatives.
Participate in quality and population health committees to enhance healthcare delivery.
Patient Care & Engagement
Conduct telehealth visits for patients lost to follow-up or those who have not had a clinic visit in the last 12 months to close care gaps.
Perform chronic condition reviews via in-office and virtual visits to ensure comprehensive management.
Provide care by in high-impact clinics, including conducting Pap smears, ordering pediatric vaccinations, and performing telephonic follow-up calls for post-discharge patients.
Take health histories, perform physical examinations, and assess patient health status as well as order, review, and interpret diagnostic and screening procedures.
Education & Mentorship
Educate primary care clinicians on quality measures and best practices for closing care gaps.
Serve as a mentor to community clinicians, providing guidance on integrating quality measures into workflows.
Promote best practices in chronic care management, including HEDIS measures and transitional care interventions.
Clinical Decision Making & Quality Improvement
Serve as an expert resource in population health and quality care initiatives.
Initiate orders for medications and therapeutic devices as appropriate.
Collaborate with other nurse practitioners and physicians to review and enhance healthcare protocols.
Provide input into clinical decision-making via participation on committees and interdisciplinary team discussions.
Required Experience and Competencies
Master's or Doctorate degree in Nursing from an accredited institution.
Active California Nurse Practitioner (NP) license.
National certification as a Nurse Practitioner in Family, Adult-Gerontology, or a related specialty.
Minimum of 2 years of experience as a Nurse Practitioner, preferably in population health, primary care, or a value-based care setting.
A passion for population health, quality measures, and patient-centered care.
Experience with telehealth services and managing chronic conditions.
Strong understanding of quality measures, care gap closure, and value-based care models.
Excellent communication, collaboration, and mentorship skills.
Ability to work both independently and as part of a multidisciplinary team.
The Practice
Arrowhead Family Health Center - Westside - Rialto, California
Arrowhead Family Health Center - McKee - San Bernardino, California
Arrowhead Family Health Center - Fontana - Fontana, California
Arrowhead Regional Medical Center - Colton, California
Arrowhead Regional Medical Center is a 456-bed university-affiliated teaching hospital licensed by the State of California Department of Public Health, operated by San Bernardino County, and governed by the Board of Supervisors.
The hospital, located on a 70-acre campus in Colton, California, operates the Edward G. Hirschman Burn Center, a trauma center, comprehensive stroke center, a behavioral health center, and five family health centers.
Arrowhead Regional Medical Center also provides more than 40 outpatient specialty care services.
Vituity-staffed Emergency Department and acute psychiatry offer integrated care solutions at this site.
Hybrid work model with up to 20% remote work available.
On-site presence required for clinical visits, team meetings, and committee participation.
Standard business hours with occasional flexibility as needed for patient and clinician engagement.
The Community
Colton, California, is a wonderful place to call home, offering a balance of suburban comfort and urban amenities.
The city provides a quiet, family-friendly atmosphere while being close to Riverside and San Bernardino.
Surrounded by beautiful mountain views, Colton offers parks like Colton City Park and access to the San Bernardino National Forest, perfect for hiking, picnicking, and outdoor recreation.
The city is near famous attractions like Riverside Plaza, the California Citrus State Historic Park, and Box Springs Mountain Reserve.
Its central location makes it easy to visit nearby landmarks, including Lake Arrowhead, Big Bear Lake, and Los Angeles.
With a rich cultural heritage, local events, and affordable living, Colton is a unique place to live and work, offering both natural beauty and access to Southern California's best attractions.
Benefits & Beyond
Vituity cares about the whole you. With our comprehensive compensation and benefits package, we are mindful of what matters most, and support your needs of today and your plans for the future.
Superior health plan options
Dental, Vision, Life and AD&D coverage, and more
Top Tier 401(k) retirement savings plans that offers a $1.20 match for every dollar up to 6%
Variety of Pre-Tax Savings Accounts including HSA, FSA, Dependent Care and Commuter Benefits
Time Off when you need it: Start with 4 weeks PTO annually and increase to 6 weeks with tenure, plus generous sick leave
Flexible scheduling for work/life balance
Yearly annual cash bonus
Professional Expense Reimbursement for medical staff dues, states licenses, DEA license, and national recertification fees
Up to $1,500 annual allowance for medical education courses and professional memberships
Student Loan Refinancing Discounts
EAP, travel assistance and identify theft included
Free education opportunities for personal and professional growth
Several wellness programs that focus on provider wellbeing and health
Diversity, Equity and Inclusion (DEI) initiatives including LGBTQ+ History, Dia de los Muertos Celebration, Money Management/Money Relationship, and more
Purpose-driven culture focused on improving the lives of our patients, communities, and employees
Salary range for this role is $65 - $70 per hour. Please speak with a recruiter for more information.
We are unified around the common purpose of transforming healthcare to improve lives and we believe everyone has a role to play in that. When we work together across sites and specialties as an integrated healthcare team, we exceed the expectations of our patients and the hospitals and clinics we work in. If you are looking to make a difference, from clinical to corporate, Vituity is the place to do it. Come grow with us.
Vituity appreciates differences; our dedication to diversity, equity and inclusion is at the heart of our organization. Vituity does not discriminate against any person on the basis of race, creed, color, religion, gender, sexual orientation, gender identity/expression, national origin, disability, age, genetic information (including family medical history), veteran status, marital status, pregnancy or related condition, or any other basis protected by law. Vituity is committed to complying with all applicable national, state and local laws pertaining to nondiscrimination and equal opportunity.
Benefits for part-time and per diem vary. Please speak to a recruiter for more information.
Applicants only. No agencies please.
Weights and Research Coordinator
Clinical Research Coordinator Job 36 miles from Laguna Hills
Weights and Research Coordinator, $68,640.00 - $72,000.00 yearly Full-Time Monday-Friday, Various Shifts are available. PTO available after the first 90 calendar days of employment. Come and experience the difference with R+L Carriers R+L Carriers has immediate opportunities for a W&R Coordinator at our Montebello, CA Service Center, to Ensure R&L Carriers receives the appropriate revenue on shipments, The W&R Coordinator will review shipments as they pass across their respective docks to verify the accuracy of the actual class of the shipment compared to that of the bill of lading information.
Requirements:
* Any type of LTL experience preferred but not required
* Ability to self-motivate and self-manage
* Willingness to learn
* Analytical skills
* Computer proficiency
* Able to work in a fast-paced environment
Excellent Benefits
R+L Carriers offers an excellent compensation and comprehensive benefits package, including Medical/Dental/Vision Insurance, 401(k) Retirement Plan with matching contributions, Paid Vacation & Holidays, and vacation lodging at our exclusive employee resorts in Daytona Beach, FL, Big Bear Lake, CA, Pigeon Forge, TN and Ocean Isle Beach, NC.
Click here ****************************
Click here ****************************
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Clinical Research Associate Manager
Clinical Research Coordinator Job 3 miles from Laguna Hills
At SpyGlass Pharma, we are focused on improving and preserving the vision of patients suffering from chronic eye conditions, while minimizing the impact on their daily lives. We aim to achieve this by developing cutting-edge long-term drug delivery products to address common causes of blindness and getting these products to the patients that need them.
We have built a team of driven professionals
with diverse expertise in ophthalmic products and drug delivery. Our accomplished scientists and engineers work alongside a seasoned leadership team with extensive experience in ophthalmology and a history of commercial success. Our unifying mantra, “We create for patients” doesn't just live on our walls but drives our decision making as we build the company, creating the products, processes and culture that make it happen.
This team has delivered a solid foundation of development and clinical data, enabling over $120 million in funding to date with several top-tier venture partners. We are building confidence in the performance of our lead product going into Phase 3 clinical trials.
Summary:
We are seeking a Clinical Research Associate (CRA) Manager to join our team at SpyGlass Pharma. The CRA Manager is responsible for leading and managing a team of field-based Clinical Research Associates who monitor clinical trials at investigative sites. This position ensures that clinical trials are conducted in compliance with study protocols, Good Clinical Practice (GCP), FDA regulations, and applicable standard operating procedures (SOPs). The CRA Manager will oversee the planning, execution, and management of site monitoring activities to ensure data integrity and patient safety.
Essential Duties & Responsibilities:
Manage, mentor, and provide leadership to a team of field-based CRAs, fostering professional development and high-performance standards.
Oversee site selection, initiation, monitoring, and close-out visits to ensure compliance with study protocols and regulatory requirements.
Develop and implement monitoring plans and strategies to optimize site performance and data quality.
Collaborate with cross-functional teams, including Clinical Operations, Data Management, and Regulatory Affairs, to support clinical trial objectives.
Ensure that CRAs are adequately trained on study protocols, SOPs, and regulatory requirements.
Review monitoring reports and provide feedback to CRAs to ensure consistency and adherence to monitoring standards.
Identify and resolve site-related issues and escalate as appropriate to senior management.
Participate in the development and review of study documents, including protocols, case report forms, and informed consent forms.
Contribute to the development and improvement of departmental processes and SOPs.
Maintain up-to-date knowledge of GCP, FDA regulations, and industry best practices to ensure compliance.
Qualifications Required For Position:
Bachelor's degree in life sciences, healthcare, or a related field; advanced degree preferred.
10 years of clinical research experience in the pharmaceutical or medical device industry, with at least 2 years in a supervisory or managerial role overseeing field-based CRAs. (A commensurate combination of education and experience will be considered.)
Strong knowledge of clinical trial monitoring practices, GCP, FDA regulations, and clinical trial management systems.
Proven ability to lead, mentor, and develop a team of clinical professionals.
Excellent verbal and written communication skills, with the ability to interact effectively with cross-functional teams and external partners.
Strong organizational and problem-solving skills with keen attention to detail.
Ability to travel up to 30-50% domestically as required.
Proficiency in Microsoft Office Suite and experience with electronic data capture (EDC) systems.
Why SpyGlass Pharma?
We are offering a range of $150,000 - $175,000, based on experience and qualifications, along with an Annual Bonus opportunity.
Share in our success with stock options, giving you a stake in the company's future.
Comprehensive health, dental, and vision insurance plans to keep you and your family healthy and happy, with a variety of plan and coverage options.
Generous paid time off, including holidays, vacation days, and personal leave.
SpyGlass Pharma is an Equal Opportunity Employer and participates in E-Verify. SpyGlass Pharma takes pride in maintaining a diverse environment and our policies are not to discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity, marital or veteran status, disability, or any other legally protected status.
SpyGlass Pharma is also committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an email to *********************** and let us know the nature of your request and your contact information.
Clinical Research Associate, Sponsor Dedicated, Oncology or Immunology
Clinical Research Coordinator Job 37 miles from Laguna Hills
Join our team as a Clinical Research Site Manager, where you'll play a crucial role in ensuring our study sites operate seamlessly and adhere to all protocols, regulations, and sponsor requirements.
Essential Functions
Site Monitoring: Conduct selection, initiation, monitoring, and close-out visits in line with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
Recruitment Management: Collaborate with sites to develop, drive, and track recruitment plans, enhancing predictability and meeting project needs.
Training & Communication: Provide protocol training and maintain regular communication with sites to manage expectations and address issues.
Quality Assurance: Evaluate site practices for protocol adherence and escalate quality issues as needed.
Study Progress: Track regulatory submissions, recruitment, enrollment, case report form (CRF) completion, and data query resolution. Support the start-up phase as required.
Documentation: Ensure all site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) according to GCP/ICH and local regulations.
Mentorship: Mentor clinical staff through co-monitoring and training visits.
Collaboration: Work closely with study team members to support project execution.
Travel: 6-10 DoS per month typical expectation, can be exceptions given the nature of the position.
Qualifications
Education: BS Degree in a scientific discipline or healthcare preferred.
Experience: At least 2.5 years of on-site monitoring experience, with a preference for oncology or immunology.
Knowledge: In-depth understanding of GCP and ICH guidelines.
Skills: Proficiency in Microsoft Word, Excel, and PowerPoint, and adept at using laptops, iPhones, and iPads.
Communication: Strong written and verbal communication skills with a good command of the English language.
Organization: Excellent organizational and problem-solving skills.
Management: Effective time and financial management abilities.
Interpersonal: Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at **********************
IQVIA is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other status protected by applicable law. **********************/eoe
The potential base pay range for this role, when annualized, is $87,200.00 - $189,000.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.
Clinical Research Associate- West Coast
Clinical Research Coordinator Job 50 miles from Laguna Hills
As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What you will be doing: Study Planning * Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
* Assume ambassadorial role to facilitate communication between sites to increase value proposition to investigators.
* Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
* Negotiate investigator remuneration; prepare financial contracts between investigational sites and investigators. Ensure adherence to payment schedule.
Study Execution
* Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
* Identify problems at sites; resolve issues and escalate as appropriate.
* Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
* Complete preparation and generation of visit monitoring reports as per relevant SOP
* Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
* If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues
Study Close-out
* Implement site close-out activities and generate site close-out report.
* Provide feedback on site performance for future trial site feasibility/selection
General
* Improve skills by timely completion performance of assigned global and local training.
You are:
* Minimum 18 months prior monitoring experience with global trials.In-depth knowledge of FDA regulations and ICH/GCP guidelines
* Bachelors of Science
* Excellent interpersonal and communication skills (verbal & written), including proficiency in medical terminology and computer systems
* Ability to work effectively with investigators and other research personnel, maintaining a professional demeanor
* Ability to independently resolve site or study related issues
* Self motivated; detail oriented; team player; flexible
* Ability to prioritize workload to meet project timelines, while managing multiple protocols across therapeutic areas
* Excellent organizational and time management skills
* Function effectively with high degree of personal accountability
* CCRA or SoCRA certified
*
Pay Range ($73,864.00 - $92,330.00 USD)
Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.
Thank you!
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
* Various annual leave entitlements
* A range of health insurance offerings to suit you and your family's needs
* Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
* Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
* Life assurance
* Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
*****************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Clinical Research Associate
Clinical Research Coordinator Job 50 miles from Laguna Hills
Piper Companies is currently seeking a Clinical Research Associate (CRA) for an opportunity in Los Angeles, California (CA). The Clinical Research Associate (CRA) will participate in ongoing Clinical Trials throughout the Country for a leading Clinical Research Organization.
Responsibilities for the Clinical Research Associate:
* Conduct site and study visits and perform all site monitoring activities across multiple study
* Responsible for both remote and on-site monitoring and study activation
* Participate in the development of study tools, protocols, and clinical trial documentation
* Some travel required once travel bands are lifted
Qualifications for the Clinical Research Associate:
* 2-4 years performing on-site monitoring and hands on experience with EDC Systems
* Experience with Oncology is highly advantageous
* Organization to perform monitoring duties across multiple sites is a must
Compensation for the Clinical Research Associate:
* Salary Range: $100,000-$120,000
* Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave as required by law, and Holidays
#LI-SR1
Sr. Clinical Research Finance Coordinator Post-Award - The Angeles Clinic & Research Institute
Clinical Research Coordinator Job 50 miles from Laguna Hills
Company DescriptionJobs for Humanity is partnering with CEDARS-SINAI to build an inclusive and just employment ecosystem. Therefore, we prioritize individuals coming from the following communities: Refugee, Neurodivergent, Single Parent, Blind or Low Vision, Deaf or Hard of Hearing, Black, Hispanic, Asian, Military Veterans, the Elderly, the LGBTQ, and Justice Impacted individuals. This position is open to candidates who reside in and have the legal right to work in the country where the job is located.
Company Name: CEDARS-SINAI
Job Description
Grow your career at Cedars-Sinai!
The Angeles Clinic & Research Institute has established an international reputation for developing new cancer therapies, providing the best in experimental and traditional treatments, and expertly guiding and training the next generation of clinicians. Our board-certified fellowship-trained medical oncologists, surgeons, immunotherapists, pathologists, and dermatologists work closely together to advance cancer care. We are committed to bringing innovative therapeutic options to all of our patients with cancer!
Join our team and contribute to groundbreaking research!
Job Summary:
This position functions as a Sr. Clinical Research Finance Coordinator, responsible for coordinating and executing the financial billing of clinical trials, formation of the Medicare Coverage Analysis grid, and the development of clinical trial budgets. He/She is responsible for the calculation of statistical, fiscal, and metric data as it relates to clinical trial activities. The Sr. CRFC also assures the building of budgets/contract agreements within the Clinical Trial Management System (CTMS). This individual will interact with principal investigators, subjects, clinic and research staff, laboratory staff, medical
professionals, pharmaceutical staff, and Sponsor representatives to successfully oversee the research billing aspects of the
Medical Care Foundation.
Primary Duties and Responsibilities
• Develops and updates Medicare Coverage Analysis grids in order to assess which procedures/services within the protocol
are covered under Medicare guidelines. Works in conjunction with Cedars-Sinai Industry Sponsored Research Office in
order to produce a final document.
• Routinely monitors and reconciles trial accounts to ensure timely deposit, correct allocation, and distribution of revenue.
• Provides financial related data as needed, to internal team members and/or manager/director.
• Work with Accounts Payable to process and monitor that timely payments are made to various internal groups, external
partners, patients, and/or joint sites according to contractual/budgetary agreement.
• Responsible for accurate and timely fiscal data collection, documentation, entry and reporting into CTMS, including timely
response to sponsor communication.
• Develop and maintain statistical and fiscal reports as they relate to clinical trial activity on a monthly and fiscal year
basis.
• Process timely invoices which follow protocol driven procedures according to patient accruals/visits in order to seek
reimbursement from industry sponsors.
• Oversees and monitors billing work queue within the Electronic Medical Records system (EPIC) and adjudicates patient
bills according to final contract/budget.
• Critically evaluates research protocols to assess resource needs; assessment includes all research procedures, clinical
research staff time, investigator time, and costs from ancillary departments.
• Develops clinical trial budgets and negotiates with industry sponsors. Renegotiates budgets as part of trial maintenance
through amendments.
• Creates and finalizes payment terms (contract language) in conjunction with industry sponsor.
• Ensures compliance with all federal and local agencies including the FDA and IRB Maintains strict patient confidentiality
according to HIPAA regulations and applicable law.
• Perform other duties as assigned
Educational Requirements:
High School Diploma/GED (Minimum)
Bachelor's Degree (Preferred)
2 years Clinical research budgeting/billing required
CCRP - Certification In Clinical Research preferred
Physical Demands:
Perform continuous operation of a personal computer for four hours or more.
Use hands and fingers to handle and manipulate objects and/or operate equipment.
Working Title: Sr. Clinical Research Finance Coordinator Post-Award - The Angeles Clinic & Research Institute
Department: Angeles Research
Business Entity: Cedars-Sinai Medical Care Foundation
Job Category: Academic/Research
Job Specialty: Contract & Grant Budgeting/Funding
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$28.52 - $44.21
Clinical Research Associate I - Soft Tissue Sarcoma
Clinical Research Coordinator Job 41 miles from Laguna Hills
Clinical Research Associate I - Soft Tissue Sarcoma - (10028267) Description Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research.
A Clinical Research Associate I role is available in the Department of Surgery under Dr. William Tseng. His research is focused on clinical (patient-oriented) research and clinical trials in Soft Tissue Sarcoma.
As a CRA I you will be responsible for managing an assigned set of clinical research studies and protocols to assure efficiency and regulatory compliance. You will also be responsible for the collection, registration, and submission of data as well as maintaining a system for effective biospecimen collection, movement, and storage, as well as data flow associated with research protocols.
As a successful candidate, you will:
· Conduct protocol management to include maintaining current and accurate protocol documentation, interfacing with Disease Team and abiding by procedural requirements
· Complete and maintain regulatory documents for IRB
· Recruit patients to studies. Establish and maintain relationships with patients, patient's other provider(s) and their staff as well as exploring ways to improve patient recruitment to studies
· Collect patient data to enter into databases for studies
· Collect and deliver surgical specimens (e.g., tumor tissue) for biorepository, analysis and external collaboration
· Work on data abstraction and analysis
· Assist PI with write-up of results Qualifications Your qualifications should include:
· Associates degree. Experience may substitute for minimum education requirements. Bachelors preferred.
· One year of experience working in a health care setting, preferably in clinical research
· Experience with medical record review, health information systems, and/or clinical trials is preferred
· Experience with Epic, IRIS and/on OnCore is preferred
City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.
City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity and inclusion, please click here
To learn more about our Comprehensive Benefits, please CLICK HERE. Primary Location: United States-California-DuarteJob: Clinical ResearchWork Force Type: HybridShift: DaysJob Posting: Jan 8, 2025Minimum Hourly Rate ($): 32.000000Maximum Hourly Rate ($): 41.554100
Clinical Research Associate - Oncology - Los Angeles
Clinical Research Coordinator Job 50 miles from Laguna Hills
As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What will you be doing?** + Works on multiple trials within Oncology + Quality of life focus wtih Regional Travel
+ Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes - Mentors/coaches junior flex team
+ Acts as Lead SM-training other SMs on study
+ Develops site start up documents for studies including SIV agenda
+ Provides SM "voice" when reviewing study documents (e.g. Monitoring Guidelines)
+ Represents LTMs or SMs on SMTs/meetings
+ Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
+ Supports country budget development and/or contract negotiation in liaison with CCS colleagues
+ Assists with ASV
+ Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces - Primary/Other:
+ Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
+ Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)
**What do you need to have?**
+ Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
+ Must be located in the LA area near a major airport
+ Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
+ Have a minimum of 1-3 years' experience monitoring Oncology trials
+ Knowledge of several therapeutic areas
+ Analytical/risk-based monitoring experience is an asset
+ Ability to actively drive patient recruitment strategies at assigned sites
+ Ability to partner closely with investigator and site staff to meet all of our study timelines
+ Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
+ Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
+ Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
+ Need to travel up to 50%
+ To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
**What ICON can offer you:**
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
+ Various annual leave entitlements
+ A range of health insurance offerings to suit you and your family's needs
+ Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
+ Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
+ Life assurance
+ Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
*****************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Clinical Research Associate 1
Clinical Research Coordinator Job 50 miles from Laguna Hills
Responsible for providing Clinical Research support for all clinical trials. Under the direction of supervisor or designee, this position will serve as support for the clinical study team.
Essential Duties And Responsibilities
Participate and assist in design and preparation of protocols and case report forms.
Generate clinical SOPs, policies, charters, and plans according to US and international guidelines.
Participate in the evaluation of potential clinical sites according to established criteria of acceptability.
Responsible for procurement of budgets, contracts, regulatory documents, and other administrative documents as related to clinical research functions.
Initiate studies performing initiation site visits, arrange for shipment of clinical supplies, case report forms, and other necessary materials.
Conduct ongoing study monitoring, including frequent periodic site visits, protocol adherence checks, material handling procedures, inspection of study files, and related monitoring functions.
Prepare site visit reports with identification of key accomplishments, key issues for resolution and recommendations for follow-up actions for assigned study sites.
Conduct study termination visits, obtain final reports from investigators, and participate in the preparation of final reports for regulatory submission.
Assist with the maintenance of clinical archive and electronic files.
Other tasks as assigned.
Requirements
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
BA, BS, RN, BSN or equivalent
Basic knowledge and adherence to GCPs
1-2 years of clinical research experience or equivalent experience or training
Strong attention to detail
Ability to multi-task
Unquestionable integrity and highest ethical standards
Excellent written and verbal communication skills
Self-motivated, assertive, and driven
BenefitsDental, Medical, Vision, PTO and 401K
Clinical Research Associate - Oncology - Los Angeles
Clinical Research Coordinator Job 50 miles from Laguna Hills
As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Responsibilities
What will you be doing?
Works on multiple trials within Oncology
Quality of life focus wtih Regional Travel
Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes • Mentors/coaches junior flex team
Acts as Lead SM-training other SMs on study
Develops site start up documents for studies including SIV agenda
Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)
Represents LTMs or SMs on SMTs/meetings
Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
Supports country budget development and/or contract negotiation in liaison with CCS colleagues
Assists with ASV
Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces - Primary/Other:
Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)
Qualifications
What do you need to have?
Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
Must be located in the LA area near a major airport
Have a minimum of 2 -3 years' experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience monitoring Oncology trials
Knowledge of several therapeutic areas
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
Need to travel up to 50%
To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
*****************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Clinical Research Associate
Clinical Research Coordinator Job 37 miles from Laguna Hills
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: Clinical Research Associate
Job Location: Carlsbad
Responsibilities:
* Clinical trial design in partnership with Director of Clinical Research and the Clinical team.
* Coordinate with other departments as necessary for meeting clinical trial and other R&D initiative timelines.
* Ensure alignment with regulatory standards, including GCP, GMP, and all other applicable regulatory authorities and guidelines.
* Assists with the development and approval of clinical trial documents.
* Conduct scheduling, recruitment, pre-screening and enrollment activities for in-house clinical studies in a Clinical Research Coordinator capacity.
* Ensure the effective execution of in-house clinical trials through maintaining accurate clinical supply inventory.
* Coordination with clinical sites during study start up to ensure delegated staff trainings on devices, cameras, and other instruments for aesthetic studies in accordance with the study protocol.
* Coordination with clinical sites in accordance with HIPAA and privacy laws to ensure appropriate storage and organization of raw data and images for all clinical studies.
* Work with vendors to ensure timely calibration and maintenance of all Sponsor owned clinical devices and equipment and assist with the procurement of new devices, equipment and supportive materials.
* Cross-functional collaboration, working closely with the formulations, operations, and marketing teams to ensure clinical materials align with company goals.
* Build positive relationships with clinical trial investigators and their research team.
* Coordinate and oversee other key research studies/activities as requested by the Director of Research.
* Coordinate the delivery and logistics of clinical trial related materials in collaboration with the clinical team.
* Ability to create compelling, results-driven clinical Before & After content for a range of channels including digital, print, and in-person marketing materials to help substantiate product claims.
Requirements:
* Bachelor's degree required, or equivalent education and with directly related years of experience. Master's degree preferred.
* 3+ years of experience executing pharmaceutical or cosmeceutical clinical studies preferred, with knowledge of medical terminology.
* Experience working with industry sponsored clinical trials.
* Experience working in cosmetic and medical dermatology preferred.
* Strong interpersonal and communication skills with ability to work independently, cross-functionally and as part of a team.
* Detail-oriented, with good organizational, prioritization and time management proficiencies. Must be able to work on multiple projects simultaneously.
* Ability to maintain timelines and coordination of multiple clinical R&D projects to ensure timely execution. Must be able to work on multiple projects simultaneously.
* Ability to problem solve and troubleshoot challenges in a timely manner.
* General knowledge of current dermatological device systems, instruments, and products preferred.
* Proficient in Microsoft Office (Word, Excel, Power Point) and Web presentation tools.
* Ability to organize and prioritize tasks to maximize results, provide timely reports, and arrange meetings for the clinical team.
* Ability to communicate effectively both verbally, and in writing.
* Ability to create professional reports, presentations, and reporting.
* Dedication and embodiment of our core values.
* Must possess a valid driver's license.
* 15% travel may be required.
Physical Requirements:
* Must be able to remain in a stationary position for long periods of time, and frequently stoop, bend, and kneel.
* This position will also be required to drive to local clinical sites and coordinate sample pick-ups and drop-offs to the local lab in Carlsbad.
* Requires preparing shipments to clinical trial sites, printing clinical study source and regulatory documents, preparing subject and regulatory binders, labeling IP and preparing ancillary supply kits.
* Ability to lift up to 15 lbs.
Clinical Research Associate
Clinical Research Coordinator Job 31 miles from Laguna Hills
Job Title: Clinical Research Associate - Early Development Oncology - US
Job Contract Type: Full-time
Job Seniority Level: Entry level
As a CRA you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What will you be doing?
Works on multiple oncology early development trials
Quality of life focus wtih Regional Travel
Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes
Mentors/coaches junior flex team
Develops site start up documents for studies including SIV agenda
Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines)
Represents LTMs or SMs on SMTs/meetings
Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial
Supports country budget development and/or contract negotiation in liaison with CCS colleagues
Assists with ASV
Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.
Interfaces - Primary/Other
Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials.
Other Interfaces: Study Responsible Physician, Regional Quality and Compliance. Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)
Qualifications Needed
US; Located near a major airport
Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
Have a minimum of 1 - 2 years' experience in monitoring pharmaceutical industry clinical trials
Have a minimum of 1-3 years' experience monitoring Oncology Early Development trials
Oncology Phase I and II experience required.
Analytical/risk-based monitoring experience is an asset
Ability to actively drive patient recruitment strategies at assigned sites
Ability to partner closely with investigator and site staff to meet all of our study timelines
Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.
Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
Need to travel up to 40%
To qualify, applicants must be legally authorized to work in the US, and should not require, now or in the future, sponsorship for employment visa status
What ICON Can Offer You
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our Benefits Examples Include
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: ************************************
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
*****************************************************
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
Lifelancer ( ********************** ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.
For more details and to find similar roles, please check out the below Lifelancer link.
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Clinical Research Associate
Clinical Research Coordinator Job 37 miles from Laguna Hills
Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: Clinical Research Associate
Job Location: Carlsbad
Responsibilities:
Clinical trial design in partnership with Director of Clinical Research and the Clinical team.
Coordinate with other departments as necessary for meeting clinical trial and other R&D initiative timelines.
Ensure alignment with regulatory standards, including GCP, GMP, and all other applicable regulatory authorities and guidelines.
Assists with the development and approval of clinical trial documents.
Conduct scheduling, recruitment, pre-screening and enrollment activities for in-house clinical studies in a Clinical Research Coordinator capacity.
Ensure the effective execution of in-house clinical trials through maintaining accurate clinical supply inventory.
Coordination with clinical sites during study start up to ensure delegated staff trainings on devices, cameras, and other instruments for aesthetic studies in accordance with the study protocol.
Coordination with clinical sites in accordance with HIPAA and privacy laws to ensure appropriate storage and organization of raw data and images for all clinical studies.
Work with vendors to ensure timely calibration and maintenance of all Sponsor owned clinical devices and equipment and assist with the procurement of new devices, equipment and supportive materials.
Cross-functional collaboration, working closely with the formulations, operations, and marketing teams to ensure clinical materials align with company goals.
Build positive relationships with clinical trial investigators and their research team.
Coordinate and oversee other key research studies/activities as requested by the Director of Research.
Coordinate the delivery and logistics of clinical trial related materials in collaboration with the clinical team.
Ability to create compelling, results-driven clinical Before & After content for a range of channels including digital, print, and in-person marketing materials to help substantiate product claims.
Requirements:
Bachelor's degree required, or equivalent education and with directly related years of experience. Master's degree preferred.
3+ years of experience executing pharmaceutical or cosmeceutical clinical studies preferred, with knowledge of medical terminology.
Experience working with industry sponsored clinical trials.
Experience working in cosmetic and medical dermatology preferred.
Strong interpersonal and communication skills with ability to work independently, cross-functionally and as part of a team.
Detail-oriented, with good organizational, prioritization and time management proficiencies. Must be able to work on multiple projects simultaneously.
Ability to maintain timelines and coordination of multiple clinical R&D projects to ensure timely execution. Must be able to work on multiple projects simultaneously.
Ability to problem solve and troubleshoot challenges in a timely manner.
General knowledge of current dermatological device systems, instruments, and products preferred.
Proficient in Microsoft Office (Word, Excel, Power Point) and Web presentation tools.
Ability to organize and prioritize tasks to maximize results, provide timely reports, and arrange meetings for the clinical team.
Ability to communicate effectively both verbally, and in writing.
Ability to create professional reports, presentations, and reporting.
Dedication and embodiment of our core values.
Must possess a valid driver's license.
15% travel may be required.
Physical Requirements:
Must be able to remain in a stationary position for long periods of time, and frequently stoop, bend, and kneel.
This position will also be required to drive to local clinical sites and coordinate sample pick-ups and drop-offs to the local lab in Carlsbad.
Requires preparing shipments to clinical trial sites, printing clinical study source and regulatory documents, preparing subject and regulatory binders, labeling IP and preparing ancillary supply kits.
Ability to lift up to 15 lbs.