Clinical Research Manager

One GI, LLC • Mentor, OH

22h • $70,000 - $90,000 • Onsite

About The Position

The Clinical Research Manager oversees daily research operations, leads and develops the clinical research team, and ensures clinical trials are executed successfully while maintaining patient safety, regulatory compliance, and financial performance. The role includes managing staff and workflows, coordinating study execution with physicians and practice sites, maintaining compliance and quality, monitoring financial and operational performance, and supporting patient and staff education. The manager also works with leadership and investigators to identify new clinical trial opportunities and promote consistent, high-quality research operations.

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 and monitor performance.
• 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 research staff and establish project timelines, milestones, and operational plans.
• Ensure accurate study documentation, informed consent, patient eligibility assessments, and protocol adherence.
• Support patient recruitment, education, safety, and advocacy throughout 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 clinical trials and departmental growth.
• Ensure trials comply with FDA requirements, study protocols, sponsor guidelines, and applicable healthcare regulations.
• Maintain compliance with HIPAA, OSHA, Joint Commission (JCAHO) standards where applicable, and other regulatory and safety requirements.
• Develop, implement, and maintain clinical research policies, procedures, and standardized workflows.
• Monitor staff compliance, documentation quality, and study-specific requirements; advise clinical teams on protocols, informed consent, patient eligibility, and regulatory standards.
• Develop and monitor departmental budgets, 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, and communicate study progress and departmental performance.
• Maintain communication with sponsors, vendors, physicians, patients, and research team members.
• Develop educational materials for staff training, patient recruitment, and study participation.
• Serve as a liaison between the Research Department and practice locations to promote consistent, high-quality operations.
• Support education of patients and staff 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 training and development.
• Competitive health and supplemental benefits, with FSA and HSA options.
• Referral bonus when a referred candidate joins the team.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree