Clinical Research Coordinator
1 month ago
Manhattan, New York
Job Title: Clinical Research Coordinator Job Summary:
A Clinical Research Coordinator (CRC) is responsible for overseeing clinical trials and research studies. This role involves coordinating all aspects of the research process, ensuring compliance with regulatory requirements, and maintaining accurate and detailed records of research activities. Key Responsibilities: 1. Study Coordination: - Coordinate and manage clinical trials and research studies from initiation to completion. - Develop and maintain study protocols, informed consent documents, and other study-related documentation. - Ensure adherence to study timelines and milestones. 2. Participant Recruitment and Management: - Identify and recruit eligible study participants. - Obtain informed consent from participants and ensure they understand the study procedures. - Schedule and conduct study visits, assessments, and follow-ups. 3. Data Collection and Management: - Collect, record, and maintain accurate study data in compliance with regulatory requirements. - Ensure data integrity and confidentiality. - Monitor and report adverse events and protocol deviations. 4. Regulatory Compliance: - Ensure compliance with local, national, and international regulations and guidelines (e.g., FDA, ICH-GCP). - Prepare and submit regulatory documents to Institutional Review Boards (IRBs) or Ethics Committees. - Maintain up-to-date knowledge of regulatory requirements and best practices. 5. Communication and Collaboration: - Act as a liaison between study sponsors, investigators, and other research staff. - Communicate study progress, issues, and updates to relevant stakeholders. - Coordinate and participate in study meetings and site visits. 6. Training and Education: - Train and supervise research staff and study participants on study procedures and protocols. - Stay current with advancements in clinical research and attend relevant training sessions and conferences. Qualifications: - Bachelor's degree in a related field (e.g., Nursing, Life Sciences, Public Health). - Previous experience in clinical research or a related field is preferred. - Knowledge of clinical trial regulations and guidelines (e.g., FDA, ICH-GCP). - Strong organizational and time-management skills. - Excellent communication and interpersonal skills. - Attention to detail and ability to maintain accurate records. - Proficiency in computer applications and data management systems. Working Conditions: - May require occasional evening or weekend work to accommodate study participants. - Potential exposure to clinical settings and patient care environments. - Ability to travel to study sites or attend conferences as needed. Career Advancement: - Opportunities for advancement to senior coordinator or managerial positions. - Potential for further education and certification in clinical research (e.g., Certified Clinical Research Coordinator (CCRC)). This job description provides a comprehensive overview of the roles and responsibilities of a Clinical Research Coordinator. If you have any specific questions or need more details, feel free to ask!
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