Clinical Research Manager - Training and Post Approval Monitoring

The duty of the Clinical Research Manager comprises enforcing and upholding comprehensive training and post-approval monitoring schemes throughout the clinical research sites network. This position guarantees that all research staff, as well as fresh research hires and investigators, possess the essential knowledge and competencies required to perform their job roles and research duties while adhering to regulatory, quality, and organizational standards. Moreover, the role ensures that ongoing research projects follow FDA, ICH-GCP, and institutional directives and study-specific criteria dictated by review bodies such as the Institutional Review Board (IRB), Research Conflict of Interest Committee (RCOIC), External Access Data Request (EDAR), etc., and delivers updated training whenever necessary to ensure sustained compliance following issue detection.

Essential Job Function:
• Provides training sessions via in-person and virtual methods to all network sites and clinical research locations.
• Creates resources and guidelines for research team members to improve their compliance levels and overall performance.
• Creates and sustains educational materials focusing on the procedures of clinical trials, regulatory adherence, principles of Good Clinical Practice (GCP), and site-specific criteria.
• Pinpoints discrepancies in performance and puts into action tailored training interventions.
• Establishes and manages a post-approval monitoring system for ongoing projects throughout the organization.
• Assist the Director of Research with various projects and duties as instructed.
• Executes various responsibilities as directed.

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.)