Clinical Research Coordinator Jobs in Bridgewater, NJ

Job Details Job Title: Clinical Scientist Duration: 4+ months contract on w2 This role is responsible for translating and implementing non-medical scientific concepts into the design, execution, and reporting of clinical programs and studies. Key responsibilities include overseeing the integration of biomarkers, digital technologies, and data science initiatives, ensuring the successful operational implementation of these aspects. The position involves providing scientific expertise, contributing to clinical development plans, preparing study protocols and training materials, and participating in key review meetings. The role also includes collaborating with cross-functional teams, such as Data Sciences, Data Management, and Clinical Leaders, to ensure high-quality study execution, data integrity, and effective communication with clinical investigators. Responsibilities: Program/Trial Planning, Execution and Reporting Responsible for leading the translation of scientific concepts into program and study design Responsible for identifying and implementing (non-medical) scientific aspects of the program and/or study at planning, execution and reporting, including (but not limited to) integration of Biomarkers and Data Science/Digital Health initiatives into studies. Oversees the assessment, selection and operational implementation for biomarkers, digital and other endpoints (scales), imaging Accountable for shaping and implementing compound and program DEI strategy together with Clinical Leader Provides expert input in clinical development plans Contributes to the preparation of PED, study protocols and training materials for clinical studies. Prepares for and participates in Protocol review Committee (PRC) and First in Human (FIH) Committee meetings Reviews medical and scientific literature Along with SRP or Clinical Leader and global development partners, responsible for oversight and high-quality implementation and closure of the study, ensuring data integrity Responsible for the TA review and sign off on various operational plans Responsible for scientific input into HA and EC responses. In concert with operational staff, acts as a liaison between the company and clinical investigators for overarching scientific guidance and other potential non-medical aspects Works closely with Data Sciences, Data Management, Statistics, Programming, JJIT and others to ensure data are received in the manner needed to support trial outcomes Responsible for the review of the data to ensure quality and to identify data quality trends. Sets up and leads Adjudication Activities Leads data visualization (DV) meetings and ensures decisions are documented Qualifications: A minimum of a Bachelor's degree is required 3+ years of experience with medical and safety reviews

Job Responsibilities: Program/Trial Planning, Execution, and Reporting Responsible for leading the translation of scientific concepts into program and study design. Responsible for identifying and implementing (non-medical) scientific aspects of the program and/or study at planning, execution, and reporting, including (but not limited to) integration of: Biomarkers Data Science/Digital Health initiatives Oversees the assessment, selection, and operational implementation for: Biomarkers Digital and other endpoints (scales) Imaging Accountable for shaping and implementing compound and program DEI strategy together with the Clinical Leader. Provides expert input in clinical development plans. Contributes to the preparation of: PED Study protocols Training materials for clinical studies Prepares for and participates in: Protocol Review Committee (PRC) meetings First in Human (FIH) Committee meetings Reviews medical and scientific literature. Along with SRP or Clinical Leader and global development partners: Responsible for oversight and high-quality implementation and closure of the study Ensures data integrity Responsible for the TA review and sign-off on various operational plans. Responsible for providing scientific input into HA and EC responses. In concert with operational staff, acts as a liaison between the company and clinical investigators for overarching scientific guidance and other potential non-medical aspects. Works closely with: Data Sciences Data Management Statistics Programming JJIT Other relevant teams to ensure data is received in the manner needed to support trial outcomes. Responsible for the review of data to: Ensure quality Identify data quality trends Sets up and leads adjudication activities. Leads data visualization (DV) meetings and ensures decisions are documented. Top Three Skills: Medical Review Safety Review

The ideal candidate should have experience with project management and reporting tools to support R&D projects and be willing to take on administrative tasks to coordinate various requests across R&D functions. We are seeking a Project Coordinator to support the R&D Manager in managing stage-controlled new product launch phases and overseeing various R&D projects both internally and with external departments. This role will be responsible for coordinating project activities, tracking progress, managing expenses, and ensuring efficient execution of new product development processes. Additionally, the Project Coordinator will assist in procurement management, expense tracking, and administrative support to facilitate smooth project operations. The ideal candidate should have 1-2 years of project management and PM tool experience, preferably with a PMP certification, and a strong understanding of food processing and product life cycle management. Key Responsibilities: Assist the R&D Manager in managing stage-controlled new product launch phases, ensuring alignment across product development stages. Track the progress of various R&D projects, including those involving cross-functional teams and external departments. Compile and organize updates from different teams into detailed progress reports. Identify and address project delays, ensuring that timelines are met for both internal and external teams. Support project planning by monitoring project timelines and assisting with adjustments as necessary to ensure on-time completion. Oversee and track procurement requests, ensuring timely availability of materials and resources needed for projects. Maintain detailed procurement and expense records, providing reports to the finance team as required. Monitor and manage R&D lab inventory, ensuring materials are available and replenished as needed. Prepare budget, cost, and timeline reports for projects to keep stakeholders informed and ensure resource efficiency. Leverage project management tools to track and streamline project progress, ensuring efficient workflows across teams. Foster clear communication among cross-functional and external teams to ensure successful project execution. Provide administrative support to the R&D team as needed, contributing to project coordination and management. Qualifications: Bachelor's degree in Food Science, Chemistry, Engineering, or a related field. 1-2 years of project management experience, preferably in the food industry. PMP certification is a plus. Strong organizational skills with excellent attention to detail. Strong communication and collaboration skills to engage with both internal and external teams. Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint) and project management tools. Ability to manage multiple projects simultaneously and meet deadlines in a fast-paced environment. Good understanding of food processing and product life cycle management. Preferred Skills: Experience in stage-controlled new product launches within the R&D or food industry. Familiarity with project management tools. Strong analytical skills for compiling, interpreting, and presenting data.

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

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization • MS: 3 to 5 years of clinical development/clinical trial management • BS: 5 to 8 years with industrial or CRO clinical experience Experience in writing clinical portions of regulatory dossiers highly preferred • Knowledge of drug development (all clinical research process including protocol and case report form design, etc) • Knowledge of GCP/ICH guidelines and FDA regulations Additional Information $60/hr 12 MONTHS

Who We Are Celebrating 40+ Years! Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease. What You'll Do Our team is growing! At Theradex, you aren't just a number. You are part of a highly engaged team of exceptional and supportive people who pride themselves on quality monitoring, continuous learning, challenge themselves and who reap the rewards of providing first in class monitoring to our sponsors. The primary responsibilities of this position include, but are not limited to, the following: Act as the routine liaison between study site and the project team for study related issues. Ensures protection of subjects, subjects' rights, and the integrity of data through monitoring of adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures and protocol compliance. Conducts pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs and the specific project scope of work to include but not limited to: Source document review and comparison to CRF data CRF review/retrieval and data corrections IMP accountability Maintenance of on-site investigator files IEC/IRB documentation Local laboratory documentation Maintenance of investigational supplies Reviews consent process for each subject (Informed Consent Form and source documentation) Verify patient eligibility Assess protocol compliance and deviations Handling of safety and efficacy issues, including, but not limited to: Serious adverse event reports Adverse event trends Treatment failures/outcomes Conducts and documents onsite visits/contacts, including: Pre-study visits Initiation visits Routine visits Study completion visits/ Close-out visits Telephone contact Site visit report preparation within study specific timeframe Responsible for all aspects of site management as described in the study plans Proactively identify and resolve issues and potential site and study issues. Assist with regulatory and study start-up activities including contract and budget negotiations, as required. Ensure clinical data integrity and meet study timelines. Provide ongoing updates and support to project management. Mentor junior members of the team. Prepare and deliver staff training sessions. Clinical Review of individual patient listings Initial clinical review of comprehensive patient data listings Initial review of study start-up materials: SOPs, draft CRFs, completion manual, compliance forms, study prompters/calendars Assist in the day to day running of projects assigned. Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, etc. Participate in project administration as required e.g., photocopying, binder preparation, start-up pack preparation etc. Maintain current knowledge related to cancer therapy, clinical trial design and conduct, and good clinical practice through literature reviews and other educational opportunities. Perform other duties as assigned by management What You Need Level of Education At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or science-related field or equivalent experience Prior Experience At least 2 years' experience as a Clinical Research Associate with a sound track record in managing clinical trial sites Experience in monitoring oncology phase I-III studies is preferred Skills and Competencies Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements. Demonstrable multitasking and execution skills. Good interpersonal skills, including communication, presentation, persuasion, and influence. Good organizational skills, including efficiency, punctuality, and collaboration in a team environment. Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and effective in developing solutions to those problems Effective knowledge of the drug development process and the Theradex organizational structure Good communication skills: verbal and written Proficient knowledge of Outlook, Word, Excel and PowerPoint; able to utilize remote meeting/teleconferencing platforms (such as Teams, Zoom, WebEx, GoToMeeting) effectively. Additional Requirements This position involves travel as needed to meet study requirements. Ability to travel up to 50% may involve overnight stays. Valid Driver's License required and Passport preferable. Successfully pass background clearance checks which may be run on a periodic basis due to 3 rd party contractual obligation requirements. Fluent in English (written and verbal) What we offer We offer a supportive culture that puts people first. We provide a competitive compensation, CRA incentive plan and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more. Theradex is an Equal Opportunity Employer. Theradex is not accepting assistance from search firms for this employment opportunity.

Global Clinical Trials (GCT) is a contract-research organization (CRO) offering support for clinical Phase I-IV studies and post-marketing activities to various organizations. Headquartered in Princeton, USA, GCT provides local and global support through multiple operational offices and a network of reliable partners. With over 100 clinical research professionals, GCT ensures individualized attention and a full range of services following industry guidelines. Role Description This is a full-time on-site role for a Clinical Research Associate at Global Clinical Trials located in Princeton, NJ. The Clinical Research Associate will be responsible for carrying out selection, initiation, monitoring and close-out visits at the participating clinical trial centers, as well as for remote coordination of the study. Qualifications * Experience in Clinical Trials, and Clinical Operations * Excellent computer skills * Strong attention to detail and organizational skills * Ability to work effectively in a team setting * Excellent communication and interpersonal skills * Bachelor's or Master's degree in a related field

WHY VITALIEF? Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials. As a result, we are seeking a talented and enthusiastic Senior Clinical Research Coordinator to join our exceptional team (as full-time, fully benefited Vitalief employee) to support our mission and our clients' mission to impact and save lives. Reasons to work for Vitalief: You can actively contribute to our clients' mission of advancing scientific discoveries that have the potential to change patients' lives for the better. Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees. We give everyone a seat at the table - we encourage innovation. Life/work balance that includes 20 PTO (Paid Time Off) days plus 9 paid Holidays annually. Other benefits include Company paid life insurance and short / long term disability coverage; 401K retirement program; Robust healthcare plans to choose from. Salary Range: Market competitive - based on experience level. Work Location: Work is 5 days per week on-site in Newark, NJ. Possibility of working one day remote per week after acclimated. Responsibilities: Under supervision of clinical research leadership staff, the medical staff, and in collaboration with research nurse staff, performs protocol-specific tasks including patient screening, ordering tests, collecting specimens and study documentation of patient reported responses, relative to various Oncology trials. Serves as a liaison (Communicating effectively) between the organization, investigators, members of the research team (i.e., physicians, nurses, hospital, and laboratory staff), and the research sponsors - to ensure that services are coordinated and delivered to patients in a timely manner. Maintains research record (e.g., patient consent, eligibility, Case Report Forms (CRF), registration confirmation, corresponding source documents, etc.) for all patients enrolled in Oncology trials. Participates in site preparation for trials including protocol feasibility, preliminary study budget, startup meeting preparation, training staff, and preparation of IRB applications and preparation of regulatory documents, study documents and forms. Schedules and conducts trial visits by informing patients and coordinating procedures per protocol. Assesses and triages study patients appropriately for serious/unexpected adverse events (SAE), reports and records adverse events according to all applicable regulation and study protocol. Assists patients in understanding their diagnosis, treatment options, and the resources available including educating eligible patients about appropriate clinical research studies and technologies. Required Skills: Bachelor's Degree required. Minimum of 2 or more years of experience in clinical research as a Clinical Research Coordinator, with experience in patient recruiting/screening/consenting/retention; activation; regulatory compliance, data management, and ensuring Serious Adverse Events (SAEs) are completed and reported within reporting deadlines outlined in the protocol. Oncology clinical research experience is a huge plus. Strong working knowledge of current Code of Federal Regulation and Good Clinical Practice guidelines. Compassionate personality and ability to interact with patients in a clear and confident manner. Ability to work on several trials concurrently - can demonstrate versatility, “can do” attitude, and possess strong organizational, time management and prioritization skills. Ability to work collaboratively with all team members (i.e., physicians, nurses, hospital, and laboratory staff) to ensure that services are coordinated and delivered to patients in a timely manner. Needs to be communicative and responsive and know when to escalate and communicate issues to management. Capable of independent decision-making, and able to thrive in a fast-paced environment working on multiple clinical trials concurrently. Must have strong Microsoft Office skills. Any exposure to EPIC (Electronic Health Records system) and/or OnCore (Clinical Trials Management System) is a plus. PHYSICAL DEMANDS: Standing, sitting, walking, visual perception, talking and hearing. Lifting up to 20lbs. IMPORTANT NOTE: Vitalief partners with clients such as major medical centers and academic institutions that often requires all on-site resources such as prospective Vitalief consultants to be inoculated annually for Influenza and successfully pass a Mantoux Tuberculin Skin Test (TST) for Mycobacterium Tuberculosis. #LI-DNP

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description CORE JOB RESPONSIBILITIES: Assist the Clinical Research team to interface with project team members including: Clinical Research Physician, Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. Review and query of hematology/oncology data including: safety, primary efficacy variables, and laboratory data. Assist with protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). Assist with clinical study report preparation to include narrative writing Participate in adhoc meetings Qualifications KNOWLEDGE/SKILLS/ABILITIES (KSA's): Advanced Degree in Life Sciences (e.g., nursing, pharmacy or related medical field), minimum 5 years' experience in clinical research development or equivalent Oncology experience REQUIRED. Hematology experience is a plus. Protocol authoring is a plus. Data review and medical monitoring of data REQUIRED. Minimum 5 yrs experience in oncology clinical development Excellent written and verbal communication skills and interpersonal skills. Knowledge of clinical trial design, basic statistics, and data review tools Proficient at data interpretation Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions Full understanding GCP and ICH Guidelines Detail-oriented, well-organized Ability to assimilate technical and scientific information quickly Proficient in Microsoft Office (Word, Excel, PowerPoint; Microsoft project a plus), JReview, EDC (Rave) Demonstrated ability to work as part of a team Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP! I look forward to hearing from you!

As a Clinical Research Associate 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.) **You Are:** + B.S., R.N., or equivalent degree, preferably in Biological Sciences + Located in Chicago 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.

Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

Smithers PDS LLC (Pharmaceutical Development Services) brings new drugs to market by providing pre-clinical and clinical services for all phases of drug development. PDS works with customers to develop new methods, validate existing methods, as well as performing the assays necessary to analyze samples from patients on more than 100 clinical trials currently in different phases of the FDA regulated drug approval process. Our expert scientists perform large molecule bioanalysis, assay development, validation, and sample analysis at our GLP, GCP, and CLIA compliant laboratories. Smithers PDS is seeking a Study Coordinator II to join our team in Ewing, NJ. This position assists the Project Manager in performing study-related critical activities. These activities include: (1) authoring and/or QC of analytical plans and reports, Watson and Excel data retrieval, (2) QC of data tables and reports and all study supporting documentation and (3) identifying issues and deviations that affect the quality of study-related data and communicating these to the Project Manager or appropriate department manager. This position is paid on a salary basis and is classified as an exempt position. Exempt employees typically work 40 hours or more to adequately perform their responsibilities. Extended work hours may be necessary to support the business in meeting client deliverable commitments. Position is generally eligible for a hybrid work schedule with at least three days on-site once all training requirements have been adequately met and proficient performance is consistently demonstrated. Salary for range for this position is $60,000 - $75,0000 per year. Salary and job title will be commensurate with experience and qualifications. Smithers PDS offers a comprehensive health insurance package including a choice of 3 medical plans, dental insurance, vision insurance, 401K retirement plan and PTO. Primary Responsibilities • With input and supervision from the Project Manager, assist in drafting Analytical Plans and Reports to support all phases of the business (Transfer, Validation and Sample Analysis) using Smithers or client specific templates. • Assist the Project Manager with meeting client deadlines. This requires a complete understanding of the status of each active project and the agreed upon project timelines and deliverables. • Create data summary tables from Watson LIMS and various Excel spreadsheet formats. • Reviews run folders, notebooks, and other study documentation. • Assure that all run folders, data tables and reports move through the internal process including QAU in sufficient time to meet client timelines. • Assure that all QC and QA findings are responded to in a timely fashion and are complete and accurate. • Assure that all study related information is archived on date that the report is finalized. • Assist the Project Manager in supplying data releases, plans, and reports to clients. • Attend Client Conference calls and provide meeting minutes for client conference calls when required. • Other duties as assigned. Additional Requirements: • Knowledge of GLP. • Ability to multi-task and participate in multiple studies concurrently. • Ability to ensure high quality data while working under the pressure of strict deadlines. • Overtime and weekend work as required. • Work may require the use of PPE (personal protective equipment). Corporate Responsibilities: • Adherence to laboratory health and safety procedures. • Adherence to Standard Operating Procedures (SOPs) & applicable company policies/ guidelines. • Adherence to federal and/or local regulations, as applicable. Education and Experience Requirements: • Minimum of a Bachelor's Degree in the Biological Sciences or equivalent experience preferred. • Minimum of 2 years in a QC/QA role at a GLP, GMP facility, at least 1 of which occurred in an analytical laboratory environment under GLP regulation. • Immunochemistry experience is preferred. • Extremely strong competence using Microsoft Word and Excel especially with various formatting features. • Functional knowledge of Watson LIMS a plus. • Must be detail oriented, well organized with exceptional communication skills. • Must have sufficient scientific background to understand scientific concepts of ligand binding assays (biomarkers, PK, immunogenicity, and cell-based assays). • Must be familiar with all GLP requirements. #PharmaJobs #LI-MV1

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. As the Jr. Clinical Research Coordinator, you will be responsible for coordinating and facilitating the daily activities that play a critical role of the clinical studies according to the protocol, Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Sets up and conducts studies in compliance with the protocol, SOPs, applicable regulations, and GCPs. Prepares, completes, organizes, and maintains all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study-specific documents. Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information. Prepares for and conducts pre-study meetings; assures that staff working on their managed studies understand and are performing duties according to the protocol, SOPs, and GCPs. Reviews and provides feedback on draft protocols, recruiting materials, and draft clinical study reports. Coordinates scheduling subjects for visits and orders checks for subject compensation. Responds to queries from Quality Assurance and Statistics Departments. Prepares and is accountable for all Test Material for managed studies. Adheres to the study budget. Provides excellent customer service to clients and panelists and maintains positive interaction with peers and supervisors. Completes other duties or tasks assigned by the Clinic Manager and/or Supervisor. Adheres to internal standards, policies, and procedures. Performs other duties as assigned. Qualifications Bachelor's in science, or other equivalent degrees - Required Candidate must be bilingual (English and Spanish) - Required 0-1 years of experience - Preferred #IND123 Additional Information SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

Global Channel Management is a technology company that specializes in various types of recruiting and staff augmentation. Our account managers and recruiters have over a decade of experience in various verticals. GCM understands the challenges companies face when it comes to the skills and experience needed to fill the void of the day to day function. Organizations need to reduce training and labor costs but at same requiring the best "talent " for the job. Qualifications MD, PhD, or PharmD: 0 to 3 years with industry experience in clinical development and bioequivalence (BE) clinical trial management or similar experience in university, hospital or research organization • MS: 3 to 5 years of clinical development/clinical trial management • BS: 5 to 8 years with industrial or CRO clinical experience Experience in writing clinical portions of regulatory dossiers highly preferred • Knowledge of drug development (all clinical research process including protocol and case report form design, etc) • Knowledge of GCP/ICH guidelines and FDA regulations Additional Information $60/hr 12 MONTHS

Who We Are Celebrating 40+ Years! Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease. What You'll Do Our team is growing! At Theradex, you aren't just a number. You are part of a highly engaged team of exceptional and supportive people who pride themselves on quality monitoring, continuous learning, challenge themselves and who reap the rewards of providing first in class monitoring to our sponsors. The primary responsibilities of this position include, but are not limited to, the following: Provide day-to-day management and execution of projects as assigned. Assist in the preparation of project specific materials e.g., status reports, newsletters, training materials, forms/templates, study manuals/binders, visit reports etc. Maintain current knowledge related to cancer therapy, clinical trial design and conduct, and good clinical practice through literature reviews and other educational opportunities. Collaborate with other members of the project team to meet Sponsor, Theradex and project objectives of site activations (including contract and budget negotiations), regulatory readiness and data quality/cleaning, as required. Establish and maintain effective, routine communications with study sites , providing timely study updates and support to sites. Ensure site communications are documented and archived as per project requirements and Theradex Oncology SOPs. Establish and maintain effective, routine communications with the internal project team, providing timely project team updates on site related issues. Responsible for the preparation of the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies. Assist study staff with maintaining the sponsor files during the life of the study. Assist in archiving at the end of study in accordance with relevant SOPs, policies and local regulatory. Maintain up-to-date site information (including all contact details and distribution lists for reports and clinical supplies). Performs ongoing management of essential regulatory documentation at the outset and across the lifespan of a study Essential document collection, review, upload, maintenance, and close-out activities, ensuring that that sponsor and investigator obligations are being met and follow applicable local regulatory requirements and ICH/GCP guidelines. Perform Site Essential Documentation verification prior to upload into the eTMF. Performs quarterly or routine QC of assigned studies/sites in the eTMF according to Theradex Oncology SOP. Performs study tracking via the study's designated system to ensure that the study files are current, accurate and complete. Ensures protection of subjects, subjects' rights, and the integrity of data through adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance. Conducts pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs and the specific project scope of work to include but not limited to: Source document review and comparison to CRF data CRF review/retrieval and data corrections IMP accountability Maintenance of on-site investigator files IEC/IRB documentation Local laboratory documentation Maintenance of investigational supplies Subject consent and consent process review (Informed Consent Form and source documentation) Verify patient eligibility. Assess and document protocol compliance and deviations. Identification of safety and efficacy issues, with escalation as appropriate, including, but not limited to Serious adverse reports Adverse event reporting Treatment failures/outcomes Site visit report preparation within study specific timeframe Assist with all aspects of site management as described in the study plans. Proactively identify and resolve potential site and study issues. Identify and escalate data quality issues to ensure clinical data integrity. Provide support to project management via ongoing project reports and updates. May be responsible for supporting multiple studies simultaneously. Must prioritize appropriately to meet business needs to ensure on-time, quality deliverables. Perform other duties as assigned by management. What You Need L evel of Education At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or human science-related field or equivalent experience. Prior Experience At least 1 year of experience as a Clinical Research Associate (6 months if previously a CRA at Theradex Oncology) Successful completion of an approved Clinical Research / Monitoring course. Previous experience in monitoring oncology studies is preferred. Previous experience with Clinical Research Site Coordination or related fields (i.e. Regulatory Specialist) is preferred. Or Previous experience in monitoring (i.e. In-House CRA/CTA/CMA or equivalent experience) preferred. Skills and Competencies Professional attitude with good customer focus. Effective communication skills: verbal/written/presentation. Good interpersonal skills, including persuasion and influence. Able to work independently as well as in a group. Good time management, multitasking and execution skills. Good organizational skills, including efficiency, punctuality, and collaboration in a team environment. Demonstrated proficiency in Microsoft Outlook, Word, Excel and PowerPoint. Appropriate level of technical proficiency to effectively work in a remote environment and able to address minor/common technical challenges without support but will timely escalate to Information Technology Support for challenges beyond capabilities. Capable of absorbing and applying knowledge gained through internal and external trainings on protocols assigned. Knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements. Effective understanding of the drug development process and the Theradex organizational structure. Additional Requirements This position involves travel as needed to meet study requirements. Ability to travel up to 50% may involve overnight stays. Valid Driver's License required and Passport preferable Successfully pass background clearance checks which may be run on a periodic basis due to 3 rd party contractual obligation requirements. Fluent in English (verbal and written) What we offer We offer a supportive culture that puts people first. We provide a competitive compensation, CRA incentive plan and benefits package including medical, dental, vision, life insurance, STD/LTD, company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and much more. Theradex is an Equal Opportunity Employer. Theradex is not accepting assistance from search firms for this employment opportunity.

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 and 401K

Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Responsibilities will include, but are not limited to, the following: 1. Assist the Clinical Research Physician to interface with project team members including: Clinical Operations, Data Management, Statistics, Drug Safety, Regulatory and Project Management. 2. Prepare or assist with preparation of key documents e.g. Investigator Brochures, regulatory submission documents, internal or external presentations, etc. 3. Protocol preparation (writing, reviewing, amending and cross-functional facilitation as appropriate). 4. Clinical study report preparation 5. Review literature and prepare summary documents for inclusion in IB, protocols regulatory submission documents, etc. 6. Participate in Development Planning for assigned compounds. 7. Oversee and challenges the adequacy of planning for study implementation 8. In collaboration with the project physician, directs the planning and implementation of clinical programs to meet corporate and clinical research goals 9. Assist Clinical Research Physician to make recommendations, take action and provide clinical research expertise related to projects 10. Work with department managers to prioritize project/study timelines to ensure adequate staffing (e.g. data management, drug supply, clinical operations, drug safety) 11. Collaborates and supports operational activities as need be. 12. Assist in establishing project budgets 13. Assist with review of ongoing summary data including: safety, primary efficacy variables, and laboratory data. 14. Participate and present at investigator meetings 15. Participate in adhoc meetings (e.g. marketing) 16. Assist in document template design and SOP writing 17. Participate on various corporate committees 18. Assist V.P./Executive Director/Director Clinical Research and Development on special projects as required 19. Lead team meetings as required Qualifications Qualifications Prerequisite: Degree in Life Sciences (e.g., BS in nursing, pharmacy or related medical field), Skills/Knowledge Required: • Minimum 2 yrs. experience in medical or technical writing • Clinical monitoring experience preferred • Excellent written and verbal communication skills and interpersonal skills. Must be able to relate effectively to people at all levels of the organization. • Extensive medical/scientific and clinical research knowledge • Knowledge of Medical Terminology • Knowledge of clinical trial design, basic statistics, pharmacodynamics and pharmacokinetics • Proficient at data interpretation • Experience in protocol development, study report preparation, Investigator Brochure preparation, regulatory submissions • Experience in all aspects of the drug development process • Knowledge of GCP and ICH Guidelines • Experience in presenting at Investigator Meetings • Detail-oriented, well-organized • Limited travel required • Ability to assimilate technical and scientific information quickly • Clinical project management skills • Proficient in Microsoft Word, Excel, PowerPoint; Microsoft project a plus • Demonstrated ability to work as part of a team • High level of interpersonal and communication skills (written and verbal) Additional Information All your information will be kept confidential according to EEO guidelines. IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-357-1104 ASAP! I look forward to hearing from you!

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. Reporting to the Senior Director, Clinical Development, the Clinical Research Scientist will provide leadership in the direction, planning, execution, and interpretation of clinical protocols, research, data collection activities, and clinical operations. He/she will establish and approve scientific methods for design and implementation of clinical protocols and final reports. Incumbent will work with others to develop statistical plans and perform data analysis of completed clinical trials. The incumbent will support new and ongoing clinical research and clinical trials and ensure efficient and timely processing of Confidential Disclosure Agreements and Clinical Trial Agreements. Monitors adherence to protocols and determines study completion. The Clinical Research Scientist may interact with Investigational sites, clinical consultants, CRO's and other vendors. He/she will provide clinical research in therapeutic areas for purposes of Regulatory submissions and product selection and development. He/she will work directly with senior program leadership and with KOLs, investigators and CROs externally to design, execute, analyze and interpret the studies for which they are responsible. Job Description Prepare clinical-related documents with minimal supervision and routine documents independently as directed. Examples include, protocol synopses, protocols, CRFs, and supporting work for regulatory submissions such as INDs. Author abstracts and manuscripts for publication in peer-reviewed journals. Evaluate and select potential investigative sites in collaboration with Clinical Operations staff. Ability to prepare, present and defend complex aspects of protocol design and/or study data at investigator and internal meetings. Oversee and coordinate the collection of and/or collect pre-study documents Participate in data review and discrepancy resolution, team meetings/presentations with increasing levels of independence and support the Program Clinical Leader or Sr. Management as needed. Assist in managing regulatory safety reporting with the following: SAE queries and follow-up, annual reports, investigator brochures, ability to learn various databases. Critically review and synthesize complex information from reviews of the scientific and clinical literature. Qualifications Minimum 2-5 years of pharmaceutical industry clinical trial experience. Experience in immunology or endocrinology therapeutic areas is a plus. Primary experience with development of clinical trial protocols. Medical or scientific writing experience a must and familiarity with clinically applied science or pharmaceutical development. Good understanding of FDA regulatory, ICH, and GCP requirements. Excellent communication skills, written and verbal. Superior interpersonal communication and the ability to work across company disciplines and functional units. Proven ability to simultaneously manage activities associated with multiple clinical trials and programs with short timelines. Attention to detail and a commitment to high quality and on-time deliverables are key success factors. Willingness to travel up to 30% domestically and internationally. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world. As the Jr. Clinical Research Coordinator, you will be responsible for coordinating and facilitating the daily activities that play a critical role of the clinical studies according to the protocol, Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Sets up and conducts studies in compliance with the protocol, SOPs, applicable regulations, and GCPs. * Prepares, completes, organizes, and maintains all study documentation forms, including drafting protocol amendments, case report forms, Electronic Data Capture (EDC), and other study-specific documents. * Performs station and instrumentation duties on other studies as assigned, including the collection and recording of clinical information. * Prepares for and conducts pre-study meetings; assures that staff working on their managed studies understand and are performing duties according to the protocol, SOPs, and GCPs. * Reviews and provides feedback on draft protocols, recruiting materials, and draft clinical study reports. * Coordinates scheduling subjects for visits and orders checks for subject compensation. * Responds to queries from Quality Assurance and Statistics Departments. * Prepares and is accountable for all Test Material for managed studies. * Adheres to the study budget. * Provides excellent customer service to clients and panelists and maintains positive interaction with peers and supervisors. * Completes other duties or tasks assigned by the Clinic Manager and/or Supervisor. * Adheres to internal standards, policies, and procedures. * Performs other duties as assigned. Qualifications * Bachelor's in science, or other equivalent degrees - Required * Candidate must be bilingual (English and Spanish) - Required * 0-1 years of experience - Preferred #IND123 Additional Information SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time. If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call ************ for assistance and leave a message. You will receive a call back. Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.