What are the responsibilities and job description for the Clinical Research Program Manager position at The Lundquist Institute?
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
Background and Health Clearance Required
Equal Opportunity Employer/Affirmative Action/Drug-Free Workplace
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
- 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
Background and Health Clearance Required
Equal Opportunity Employer/Affirmative Action/Drug-Free Workplace
Salary : $85,000 - $130,000