Job Description

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

1. Directly supervise and manage clinical research staff, including coordinators, nurses, and research support personnel.
2. Assign staff to studies based on protocol complexity, workload demands, and individual competencies to ensure effective study execution.
3. Monitor staff performance and productivity; conduct performance evaluations and support staff development through mentoring, coaching, and corrective action as needed.
4. Oversee hiring, onboarding, training, and retention of clinical research personnel.
5. Ensure all research staff complete required regulatory, institutional, and role‑specific training and maintain ongoing competency in accordance with GCP.
6. Promote compliance with federal regulations (FDA, OHRP), Good Clinical Practice (GCP), IRB requirements, and institutional policies and procedures.
7. Identify compliance gaps and quality risks; implement corrective and preventive actions and support audit readiness, monitoring visits, and inspections.
8. Support efficient study operations by aligning staffing models with study volume and preparing operational reports, metrics, and dashboards.
9. Prepares operational reports and metrics related to study performance, staff productivity, and quality indicators.
10. 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

1. Provides subject-matter expertise related to clinical research operations, research considerations, and regulatory requirements.
2. Offers clinical insight when reviewing protocols, assessing study feasibility, and troubleshooting operational challenges.
3. Supports the development and refinement of SOPs, workflows, and quality standards supporting research.

Education and Experience

1. Education: Bachelor's degree required; bachelor's in science in Nursing (BSN) or Bachelor of Science (BS) preferred.
2. Certification: Relevant certification (CCRP, CCRC, or CCRA) preferred.
3. Years of relevant experience: Minimum of five years' experience in clinical research operations, regulatory affairs, research finance, or related areas.
4. Years of supervisory experience: Minimum of two years of staff supervisory/management experience
5. Strong working knowledge of GCP, FDA regulations, and institutional research policies
6. Demonstrated leadership, communication, and conflict-resolution skills

Full Time

FTE: 1.000000

Status: Onsite