Manager Clinical Research

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.
• Prepare 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.

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.

Schedule

Full Time, FTE: 1.000000. Status: Onsite.