Clinical Research Data and Regulatory Coordinator
About The Position
Within the Department of Clinical Research, and under funding provided by sponsor organizations, the Clinical Research Data and Regulatory Coordinator performs all duties under the general supervision of the Director of Clinical Research and/or Senior Research Nurse(s)-who are Registered Nurses licensed in the State of New Jersey and the Senior Clinical Research Coordinator(s). The Coordinator works in collaboration with the Clinical Research Team and Principal Investigator, and Sub‑Investigators while following established procedures and current protocol requirements. The Clinical Research Data and Regulatory Coordinator prepares, completes and maintains all Institutional Review Board (IRB) regulatory submissions, including initial applications, continuing reviews, safety reports, and amendments, and other required submissions in support of clinical research. The Coordinator prepares submissions for reportable events and facilitate communication and correspondence between the Clinical Research Team and sponsoring agencies. The position includes abstracting data; collecting protocol-specific information from physicians, nurses, patients, family members, local caregivers, and other authorized sources using protocol-specific methods; and obtaining informed consent from research participants in accordance with the approved protocol, IRB requirements, and applicable regulations. The Clinical Research Data and Regulatory Coordinator ensures that designated clinical research regulatory and data management activities at all clinical research sites are conducted in accordance with applicable laws, regulations, institutional policies, and protocol requirements. Additional duties may be assigned by the supervisor or described in the position description. The Clinical Research Data and The Clinical Research Data and Regulatory Coordinator ensures compliance with established data collection, documentation, and reporting requirements for assigned clinical research protocols. This position responds to and resolves inquiries from collaborating research organizations and study sponsors and prepares data reports that demonstrate the potential impact of research activities on the organization. The Clinical Research Data and Regulatory Coordinator works closely with the Clinical Research Director, Research Coordinator, research team, Principal Investigators, and Co-Investigators to establish clinical trial requirements, collect and extract necessary study information, monitor study progress, and support the successful completion of clinical trials.
Requirements
- 1-2 years of medical-related clinical experience
- Certificate of successful completion “Human Research Protection Foundational Training” from US Department of Health and Human Services (HHS), and/or “Good Clinical Practice” (GCP) from National Drug Abuse Treatment Clinical Trials Network or Collaborative Institutional Training Initiative (CITI) within two weeks of hire
- Associates degree in a science-related field
- Must be able to meet deadlines and prioritize workload and complete multi-step procedures on several studies simultaneously.
- Knowledge and experience with medical and scientific terminology and concepts.
- Effective communication and interpersonal skills effectively managing stressful situations.
- Demonstrated ability to prioritize and multitask to meet multiple deadlines.
- Fluency in English (oral and written), proficiency in MS Outlook, Word, Excel PowerPoint.
- Working knowledge of general scientific research.
- Ability to work productively independently and as part of a team.
Nice To Haves
- Certification or commensurate research and/or cardiovascular experience
- Cardiovascular experience
- Data management experience
- Regulatory experience
- Research experience
- Bachelor’s degree in a related field
- Previous experience with clinical research data collection and regulatory submissions
- Compliance management
- Auditing experience
- eTMF experience
- iMedidata experience
- REDCap experience
- Multi-lingual
Responsibilities
- Prepares, completes, and maintains all Institutional Review Board (IRB) regulatory submissions, including initial applications, continuing reviews, safety reports, and amendments.
- Prepares submissions for reportable events.
- Facilitates communication and correspondence between the Clinical Research Team and sponsoring agencies.
- Abstracts data and collects protocol-specific information from various sources.
- Obtains informed consent from research participants.
- Ensures clinical research regulatory and data management activities are conducted in accordance with applicable laws, regulations, institutional policies, and protocol requirements.
- Ensures compliance with established data collection, documentation, and reporting requirements for assigned clinical research protocols.
- Responds to and resolves inquiries from collaborating research organizations and study sponsors.
- Prepares data reports that demonstrate the potential impact of research activities on the organization.
- Works closely with the Clinical Research Director, Research Coordinator, research team, Principal Investigators, and Co-Investigators to establish clinical trial requirements, collect and extract necessary study information, monitor study progress, and support the successful completion of clinical trials.
Benefits
- Healthcare coverage for team members in regularly budgeted positions of at least 30 hours per week
- Generous paid time-off
- 401K matching contribution
- Tuition assistance
- Short and long term disability benefits
- Life insurance
- Meal discount
- Dependent care subsidy
- Adoption assistance
- Free parking
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
