Clinical Research Program Manager
Job Summary:
The CRPM is responsible for coordinating and administering clinical trials under the direction of a principal investigator. This role involves participant recruitment, data collection, regulatory compliance, and ensuring that studies follow established protocols and guidelines.
Key Responsibilities:
- Coordinate and manage all aspects of clinical research studies from initiation to close-out
- Recruit, screen, and enroll study participants according to protocol criteria
- Obtain informed consent in compliance with ethical and regulatory standards
- Schedule and conduct study visits, procedures, and follow-ups
- Collect, record, and maintain accurate study data and source documentation
- Ensure compliance with study protocols, institutional policies, and regulatory requirements (e.g., FDA, IRB, GCP)
- Monitor participant safety and report adverse events as required
- Maintain study files, regulatory binders, and case report forms
- Communicate with investigators, sponsors, and study team members
- Assist with audits and inspections by regulatory agencies
Qualifications
- Bachelor's degree in life sciences, public health, or a related field
- Experience in clinical research or healthcare (optional)
- Knowledge of clinical trial regulations and guidelines (e.g., GCP, HIPAA)
- Strong organizational and time-management skills
- Excellent written and verbal communication skills
- Attention to detail and ability to manage multiple tasks
Please ensure your application is complete and signed; incomplete submissions will not be considered.
Background and Health Clearance Required
Equal Opportunity Employer/Affirmative Action/Drug-Free Workplace
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