Clinical Research Coordinator (RN): Molecular Therapy
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.
Requirements
- RN (Registered Nurse) qualification
- Experience in clinical research activities
- Knowledge of FDA regulated research, including industry-sponsored Phase I, II, III and IV clinical trials, government funded clinical research and investigator initiated clinical research.
- Familiarity with informed consent process.
- Experience with Institutional Review Board submissions.
- Proficiency in subject recruitment.
- Experience with accurate data collection and completion of case report forms (CRFs).
- Experience with adverse event reporting.
- Experience with subject follow-up.
- Experience with maintenance of regulatory binders.
- Experience with study budget preparation and fund tracking/distribution.
- Experience submitting data to Sponsors.
- Experience assisting with monitoring, auditing and close-out visits.
- Knowledge of best practices and standards for Good Clinical Practices.
- Knowledge of protection of human subjects in research practices.
- Knowledge of FDA regulatory guidelines regarding clinical research.
Responsibilities
- Responsible for all aspects of clinical research activities.
- Provides support, coordination and leadership for FDA regulated research including drug/device/biologic studies.
- Ensures smooth, accurate process of clinical studies from planning and approval stages through study completion and post-study closure.
- 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 while obtaining informed consent.
- Assists in scheduling follow-up visits for enrolled subjects.
- 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.
- 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.
- Works as a team member to support growth and vision of the Hoag Institute for Research and Education.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
