Clinical Research Manager

One GI, LLC•Mentor, OH

8d•$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. This leadership role is based in a fast-paced healthcare environment and focuses on team development, operational excellence, expanding research opportunities, and delivering exceptional patient experiences. The manager supervises and mentors Clinical Research Coordinators and other research staff; coordinates with physicians, investigators, and practice sites; and manages trials from planning and initiation through monitoring and completion. The role also supports patient recruitment, education, safety, and advocacy, and coordinates study medications, laboratory procedures, specimen collection, and related clinical activities. The position is responsible for regulatory compliance and quality, including maintaining policies and workflows and monitoring documentation and staff compliance. It also includes budgeting, study financial performance, operational reporting, resource management, and collaboration with sponsors, vendors, patients, physicians, and practice locations.

Requirements

BSN, Associate Degree in Nursing, or Nursing Diploma required.
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 required.
Understanding of healthcare systems, policies, procedures, and clinical operations.

Responsibilities

Manage, supervise, train, and mentor Clinical Research Coordinators and other research department staff.
Oversee daily 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 research 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 throughout clinical trials.
Coordinate study medications, laboratory procedures, specimen collection, and other clinical activities as required.
Collaborate 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 standards where applicable, and other relevant regulatory 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, emphasizing 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 effective 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 research operations.
Support education of patients and staff to encourage safe, informed, and successful participation in clinical research.