Clinical Research Coordinator
3 days ago
We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our team at Children's National. The successful candidate will play a critical role in the day-to-day operations of clinical research studies, ensuring the highest level of quality and compliance with regulatory requirements.
Key Responsibilities:- Participate in or lead the day-to-day operations of clinical research studies, including data collection, compilation, and analysis.
- Develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations.
- Direct the work of junior staff, train personnel, and direct the work of a Clinical Research Assistant as assigned.
- Ensure regulatory integrity of protocols through the accurate and timely preparation and submission of documents and reports to the sponsor, IRB, and other oversight bodies.
- Collect, prepare, process, ship, and maintain accurate inventory of research specimens, and train others in performing these tasks.
- Author study documents, including informed consents, protocol-specific source documents, and IRB contingency responses.
- Register and record participant visits in the appropriate tracking system.
- Anticipate study needs and subject caseload in order to meet organizational objectives and deadlines in a timely manner.
- Bachelor's Degree in a science, technical, health-related field, or other applicable discipline.
- 1 year of applicable work, research, or internship experience (e.g., research assistant, data manager, clinician, or other interaction with a research population).
- Strong knowledge of GCP, OHRP regulations, and FDA regulations.
- Excellent communication and interpersonal skills.
- Ability to work independently and as part of a team.
This position is located at Children's National Hospital in Washington, D.C. and requires a full-time schedule with regular working hours.
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