Clinical Research Manager

One GI, LLC; Mentor (OH); Hybrid; USD 85,000 - 130,000; Full time

Benefits offered by this job

Paid time off

401(k) employer match

Education reimbursement

Internal growth opportunities

Health and supplemental benefits (FSA,

HSA options

Referral bonus

Job summary

One GI, LLC seeks an experienced Clinical Research Manager to lead our research team and oversee study operations across trials. You will supervise CRCs, coordinate initiation to completion, and ensure patient safety and regulatory compliance.

You will manage budgets, sponsor communications, and site collaborations while driving operational excellence and research quality in a fast-paced healthcare setting.

Qualifications

• Requires nursing education (BSN, ADN, or diploma).
• Minimum two years Clinical Research Coordinator experience.
• Proven leadership and staff development abilities.
• Solid knowledge of FDA regulations and HIPAA requirements.
• Strong clinical documentation and patient safety focus.

Responsibilities

• Lead and develop the clinical research team and CRCs.
• Oversee daily operations, staffing, and workflows.
• Coordinate study initiation, monitoring, and completion.
• Ensure regulatory compliance and quality assurance.
• Manage budgets, billing processes, and operational metrics.
• Collaborate with physicians and sites to execute trials.

Skills

Leadership experience

Clinical research leadership

Regulatory knowledge

Clinical trial operations

Communication skills

Documentation & reporting

BLS certification

Healthcare knowledge

Education

BSN or higher in nursing

Job description

NOW HIRING: Clinical Research ManagerLead Our Team. Advance Clinical Research. Make a Difference in Patient Care.Are you an experienced clinical research professional with a passion for leadership, operational excellence, and advancing patient care? We’re looking for a dynamic Clinical Research Manager to oversee daily research operations, lead and develop our clinical research team, and ensure the successful execution of clinical trials while maintaining the highest standards of patient safety, regulatory compliance, and financial performance.This is an exciting opportunity for a motivated clinical research leader who thrives in a fast-paced healthcare environment, excels at team development, and is committed to expanding research opportunities and delivering exceptional patient experiences.Awesome Perks, Just for You!Excellent paid time off for a healthy work/life balance.We’ve got your future in mind! With our generous 401(k) plan, we’ll help you grow your nest egg with an employer match that makes saving for retirement even sweeter.Looking to further your education? We want to help! We offer education reimbursement opportunities, with generous annual support based on your employment status.Internal growth opportunities. We want to aide in your training and development.Competitive health and supplemental benefits; with FSA and HSA options.Love where you work? Spread the word! Refer a friend who’d be a great fit for One GI and earn a special bonus when they join the team! What You’ll DoLead & Develop the Research TeamManage, supervise, train, and mentor Clinical Research Coordinators (CRCs) and other research department staff.Oversee daily departmental operations, staffing, workflows, and resource allocation.Delegate responsibilities, monitor performance, and promote a culture of accountability, collaboration, and continuous improvement.Coordinate with physicians, Principal Investigators, Sub-Investigators, and practice sites to support successful study execution.Oversee Clinical Trial OperationsManage clinical research studies from planning and initiation through ongoing 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 the clinical trial experience.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.Maintain Regulatory Compliance & QualityEnsure clinical trials are conducted in accordance with FDA requirements, study protocols, sponsor guidelines, and applicable healthcare regulations.Maintain compliance with HIPAA, OSHA, Joint Commission (JCAHO) 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.Provide guidance to clinical teams on research protocols, informed consent, patient eligibility, and regulatory standards.Drive Financial & Operational PerformanceDevelop 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.Build Collaborative PartnershipsMaintain effective communication with sponsors, vendors, physicians, patients, and research team members.Develop educational materials to support 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 the education of patients and staff to encourage safe, informed, and successful participation in clinical research. What You’ll BringNursing Education: BSN, Associate Degree in Nursing, or Nursing Diploma required.Clinical Research Experience: At least two years of experience as a Clinical Research Coordinator (CRC).Leadership Experience: Previous management or supervisory experience.Clinical Research Expertise: Advanced knowledge of clinical trial operations, research practices, study protocols, and regulatory requirements.Regulatory Knowledge: Working knowledge of FDA regulations, clinical trial standards, patient confidentiality, and applicable healthcare compliance requirements.Clinical Skills: Familiarity with laboratory procedures, specimen collection, screening, and clinical documentation standards.Communication Skills: Strong written, verbal, organizational, and problem-solving abilities.Documentation & Reporting: Ability to prepare research protocols, study documentation, operational reports, and educational materials.Certification: Current Basic Life Support (BLS) certification required.Healthcare Knowledge: Understanding of healthcare systems, policies, procedures, and clinical operations. Ready to Take the Next Step in Your Clinical Research Career?If you're a passionate clinical research professional with the leadership skills, clinical expertise, and operational insight to make a difference, we want to hear from you!Apply today and help us advance clinical research, empower our team, and improve patient care.