Clinical Research Manager

One GI • Mentor, OH

6d

About The Position

The Clinical Research Manager leads the research team and oversees daily clinical research operations. The role manages and develops Clinical Research Coordinators and other research staff, coordinates study execution with physicians and practice sites, and ensures clinical trials are conducted safely, effectively, and in compliance with applicable regulations and protocols. The manager also supports patient recruitment and education, maintains research quality and documentation, manages departmental financial and operational performance, and builds collaborative relationships with sponsors, vendors, patients, and organizational teams.

Requirements

• BSN, Associate Degree in Nursing, or Nursing Diploma.
• At least two years of experience as a Clinical Research Coordinator (CRC).
• Previous management or supervisory experience.
• Advanced knowledge of clinical trial operations, research practices, study protocols, and regulatory requirements.
• Working knowledge of FDA regulations, clinical trial standards, patient confidentiality, and applicable healthcare compliance requirements.
• Familiarity with laboratory procedures, specimen collection, screening, and clinical documentation standards.
• Strong written, verbal, organizational, and problem-solving abilities.
• Ability to prepare research protocols, study documentation, operational reports, and educational materials.
• Current Basic Life Support (BLS) certification.
• Understanding of healthcare systems, policies, procedures, and clinical operations.

Responsibilities

• Manage, supervise, train, and mentor Clinical Research Coordinators and other research department staff.
• Oversee departmental operations, staffing, workflows, and resource allocation.
• Delegate responsibilities, monitor performance, and promote accountability, collaboration, and continuous improvement.
• Coordinate with physicians, Principal Investigators, Sub-Investigators, and practice sites to support study execution.
• Manage clinical research studies from planning and initiation through monitoring and completion.
• Assign studies to staff and establish project timelines, milestones, and operational plans.
• Ensure accurate study documentation, informed consent processes, patient eligibility assessments, and protocol adherence.
• Support patient recruitment, education, safety, and advocacy during clinical trials.
• Coordinate study medications, laboratory procedures, specimen collection, and other clinical activities as required.
• Work with leadership and investigators to identify opportunities for new trials and departmental growth.
• Ensure compliance with FDA requirements, study protocols, sponsor guidelines, HIPAA, OSHA, Joint Commission standards where applicable, and other relevant regulations and safety requirements.
• Develop, implement, and maintain clinical research policies, procedures, and standardized workflows.
• Monitor staff compliance, documentation quality, and study-specific requirements.
• Guide clinical teams on research protocols, informed consent, patient eligibility, and regulatory standards.
• Develop and monitor departmental budgets, focusing on cost containment and operational efficiency.
• Review study budgets, pro formas, billing processes, and clinical trial financial performance.
• Monitor cash flow, study volume, staffing needs, and resource utilization.
• Prepare operational and statistical reports for physicians and organizational leadership.
• Communicate study progress, departmental performance, and opportunities for improvement.
• Maintain communication with sponsors, vendors, physicians, patients, and research team members.
• Develop educational materials for staff training, patient recruitment, and study participation.
• Liaise between the Research Department and practice locations to promote consistent, high-quality research operations.
• Support patient and staff education to encourage safe, informed participation in clinical research.

Benefits

• Paid time off.
• 401(k) plan with employer match.
• Education reimbursement opportunities, with annual support based on employment status.
• Internal growth opportunities and support for training and development.
• Health and supplemental benefits, with FSA and HSA options.
• Referral bonus.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager