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Clinical Research Manager - Training and Post Approval Monitoring
1121 North Church Street, Greensboro, NC 27401Posted 2 weeks ago
Full-timeonsite
Job Description
The Clinical Research Manager is responsible for implementing and maintaining comprehensive training and post-approval monitoring programs across the network of clinical research sites. The role ensures that all research staff and new research hires and investigators are equipped with the knowledge and skills necessary to execute their job functions and/or research responsibilities while maintaining compliance with regulatory, quality, and organization standards. Additionally, the role ensures that active research projects are conducted in accordance with FDA, ICH-GCP, and institutional policies and procedures as well as study-specific requirements made by institutional review bodies such as the Institutional Review Board (IRB), Research Conflict of Interest Committee (RCOIC), External Access Data Request (EDAR), etc., and provides re-training, as needed, to ensure ongoing compliance when issues are identified.
Essential Job Function
- Coordinates and delivers training sessions (in-person and virtual) across the network or clinical research sites.
- Implements training materials, SOPs, and resources to optimize research staff compliance and performance.
- Develops and maintains curricula covering clinical trial processes, regulatory compliance, Good Clinical Practice (GCP), and site-specific requirements.
- Identifies performance gaps and implements targeted training solutions.
- Implements and maintains a post-approval monitoring program for active projects across the system.
- Work closely with the Director of Research on other projects and tasks as requested or assigned.
- Performs other duties as assigned.
Education
- Required: Bachelors Degree
- Preferred: Masters Degree
Experience
- Required: 5-7 yrs of experience in clinical research, with at least 1-2 years in a training or leadership capacity.
Licensure/Certification/Listing
- Preferred: Certification in clinical research (ACRP, SOCRA, etc.)