Clinical Research Coordinator
9 hours ago
The Clinical Research Coordinator plays a vital role in the day-to-day operations of clinical research studies conducted by a principal investigator. This position is responsible for performing a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data.
Key Responsibilities:- Develop a progressive functional knowledge of Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations.
- Participate in or lead day-to-day operations of clinical research studies, including developing and implementing research protocols, managing research data, and ensuring compliance with regulatory requirements.
- Collaborate with research teams, investigators, and sponsors to ensure the successful completion of research studies.
- Develop and maintain knowledge of research protocols, including study procedures, timelines, and eligibility criteria.
- Accurately create, complete, maintain, and organize study documents, including informed consents, protocol-specific source documents, and IRB contingency responses.
- Ensure 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 to meet organizational objectives and deadlines in a timely manner.
- Coordinate, prepare for, and respond to routine oversight body visits and audits.
- Perform query resolution and assist with addressing and correcting audit findings.
- 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 Good Clinical Practices (GCP), Office of Human Research Protections (OHRP) regulations, and Food and Drug Administration (FDA) regulations.
- Excellent communication and organizational skills.
- Ability to work effectively in a team environment.
- Ability to maintain confidentiality of data as required.
This position is located at Children's National Hospital in Washington, D.C. and requires a strong commitment to delivering high-quality patient care and research.
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Clinical Research Coordinator
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