Manager Clinical Research

Akron Children's Hospital; Akron (OH); On-site; USD 90,000 - 120,000; Full time

Job summary

Akron Children's Hospital is seeking a Clinical Research Manager to oversee the clinical research team leads and staff, ensuring staffing, training, and day-to-day operations align with federal regulations and sponsor requirements.

The role emphasizes supervising coordinators, nurses, and support personnel; coordinating staffing for studies; and maintaining GCP competency across the portfolio to support audits and inspections. This is an onsite, full-time position based in Akron, OH.

Qualifications

• Bachelor's degree required; BSN or BS preferred.
• CCR A/CCRC/CCRA certification preferred.
• Minimum five years' experience in clinical research operations or related areas.
• Minimum two years' supervisory/management experience.

Responsibilities

• Directly supervise and manage clinical research staff, including coordinators, nurses, and research support personnel.
• Assign staff to studies based on protocol complexity, workload, and competencies to ensure effective study execution.
• Monitor staff performance and productivity; conduct evaluations and support staff development through mentoring and coaching.
• Oversee hiring, onboarding, training, and retention of clinical research personnel.
• Ensure regulatory, institutional, and training requirements are met and maintain GCP competency.
• Promote compliance with FDA, OHRP, GCP, IRB requirements and institutional policies.
• Identify compliance gaps and implement corrective actions; support audits and inspections.
• Prepare operational reports and metrics related to study performance and staff productivity.
• Serve as liaison among research staff, investigators, leadership, and cross-functional teams.

Skills

Leadership

Communication

Conflict resolution

Education

Bachelor's degree

BSN/BS preferred

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 rolespecific 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 crossfunctional 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