Clinical Research Operations Lead

OneGI; Mentor (OH); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Paid time off

401(k) match

Education reimbursement

Career growth

Health benefits (FSA/HSA)

Referral bonus

Job summary

OneGI, located in Mentor, OH, is hiring a Clinical Research Manager to lead the research team, oversee daily operations of clinical studies, and ensure patient safety, regulatory compliance, and quality. You will mentor CRCs, manage study timelines, coordinate with investigators, and drive process improvements while maintaining budgets and sponsor expectations.

This leadership role offers growth opportunities and a path to expand clinical research opportunities within OneGI, with competitive

Qualifications

• Nursing Education: BSN, Associate Degree in Nursing, or Nursing Diploma required.
• Clinical Research Experience: At least two years as a Clinical Research Coordinator (CRC).
• Leadership Experience: Previous management or supervisory experience.
• Clinical Research Expertise: Advanced knowledge of clinical trial operations, study protocols, and regulatory requirements.
• Regulatory Knowledge: Working knowledge of FDA regulations, clinical trial standards, patient confidentiality, and healthcare compliance.

Responsibilities

• Lead and develop the research team.
• Oversee daily departmental operations, staffing, workflows, and resource allocation.
• Ensure regulatory compliance and patient safety throughout trials.
• Manage clinical study operations from planning to completion.
• Coordinate with physicians and sites to support study execution.
• Develop budgets and monitor study financial performance.

Skills

Leadership

Communication

Regulatory knowledge

Clinical research

Documentation

Education

BSN / ASN / Nursing Diploma

Job description

OneGI, located in Mentor, OH, is hiring a Clinical Research Manager to lead the research team, oversee daily operations of clinical studies, and ensure patient safety, regulatory compliance, and quality. You will mentor CRCs, manage study timelines, coordinate with investigators, and drive process improvements while maintaining budgets and sponsor expectations.

This leadership role offers growth opportunities and a path to expand clinical research opportunities within OneGI, with competitive