Clinical Research Coordinator II (RN): Cell Therapy Research
About The Position
The Clinical Research Coordinator RN is responsible for all aspects of clinical research activities and works in close cooperation with study physicians. The CRC-RN provides support, coordination and leadership for FDA regulated research including drug/device/biologic studies that may involve industry-sponsored Phase I, II, III and IV clinical trials, government funded clinical research and investigator initiated clinical research. The CRC-RN ensures smooth, accurate process of clinical studies from the planning and approval stages through study completion and post-study closure. This position reports to the Director of Clinical Research. The CRC-RN is involved in all aspects of research studies from protocol review, preparation and administration of the informed consent, study submission to the Institutional Review Board, subject recruitment, accurate data collection and completion of case report forms (CRFs), adverse event reporting, scheduled subject follow-up, and maintenance of regulatory binders. Discusses research study with potential study subjects and answers any questions (may refer questions to Principal Investigator when appropriate) while obtaining informed consent as well as assisting in scheduling follow-up visits for enrolled subjects. The CRC-RN assists in developing a detailed cost analysis, study budget preparation, and tracking/distribution of study funds. Responsible for submitting case report forms and other data to the Sponsor as necessary, and assists with monitoring, auditing and close-out visits. Maintains knowledge of best practice and standards for Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research. This position reports to the Director of Clinical Research and works as a team member to support growth and vision of the Hoag Institute for Research and Education.
Responsibilities
- Protocol review
- Preparation and administration of the informed consent
- Study submission to the Institutional Review Board
- Subject recruitment
- Accurate data collection and completion of case report forms (CRFs)
- Adverse event reporting
- Scheduled subject follow-up
- Maintenance of regulatory binders
- Discussing research study with potential study subjects and answering any questions
- Obtaining informed consent
- Assisting in scheduling follow-up visits for enrolled subjects
- Assisting in developing a detailed cost analysis
- Study budget preparation
- Tracking/distribution of study funds
- Submitting case report forms and other data to the Sponsor as necessary
- Assisting with monitoring, auditing and close-out visits
- Maintaining knowledge of best practice and standards for Good Clinical Practices, protection of human subjects in research practices, and FDA regulatory guidelines regarding clinical research
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
Mid Level
Education Level
No Education Listed
Number of Employees
5,001-10,000 employees
