Summary:
The Clinical Research Manager is responsible for the direct oversight and management of clinical research team leads, staff and day-to-day research operations. This role ensures appropriate staffing of studies, staff training and development, and compliance with federal regulations, institutional policies, and sponsor requirements across the clinical research portfolio.
Responsibilities:
- Directly supervise and manage clinical research staff, including coordinators, nurses, and research support personnel.
- Assign staff to studies based on protocol complexity, workload demands, and individual competencies to ensure effective study execution.
- Monitor staff performance and productivity; conduct performance evaluations and support staff development through mentoring, coaching, and corrective action as needed.
- Oversee hiring, onboarding, training, and retention of clinical research personnel.
- Ensure all research staff complete required regulatory, institutional, and role-specific training and maintain ongoing competency in accordance with GCP.
- Promote compliance with federal regulations (FDA, OHRP), Good Clinical Practice (GCP), IRB requirements, and institutional policies and procedures.
- Identify compliance gaps and quality risks; implement corrective and preventive actions and support audit readiness, monitoring visits, and inspections.
- Support efficient study operations by aligning staffing models with study volume and preparing operational reports, metrics, and dashboards.
- Prepares operational reports and metrics related to study performance, staff productivity, and quality indicators.
- Serve as a liaison among research staff, investigators, leadership, and cross-functional teams; standardize workflows and facilitate communication to support smooth study operations.
Other information:
Technical Expertise- Provides subject-matter expertise related to clinical research operations, research considerations, and regulatory requirements.
- Offers clinical insight when reviewing protocols, assessing study feasibility, and troubleshooting operational challenges.
- Supports the development and refinement of SOPs, workflows, and quality standards supporting research.
Education and Experience- Education: Bachelor's degree required; bachelor's in science in Nursing (BSN) or Bachelor of Science (BS) preferred.
- Certification: Relevant certification (CCRP, CCRC, or CCRA) preferred.
- Years of relevant experience: Minimum of five years' experience in clinical research operations, regulatory affairs, research finance, or related areas.
- Years of supervisory experience: Minimum of two years of staff supervisory/management experience
- Strong working knowledge of GCP, FDA regulations, and institutional research policies
- Demonstrated leadership, communication, and conflict-resolution skills
Full Time
FTE: 1.000000
Status: Onsite
