Clinical Research Manager - Dean McGee Eye Institute

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Job Description:

Job Profile Summary

The Manager of Clinical Research is responsible for leading and coordinating clinical research operations across ophthalmology research programs. This role ensures regulatory compliance, operational efficiency, and strategic alignment with institutional goals. The manager oversees research staff, financial processes, and study execution while fostering collaboration among investigators, sponsors, and regulatory bodies.

Essential Responsibilities

Responsibilities listed in this section are core to the position. Inability to perform these responsibilities with or without an accommodation may result in disqualification from the position.

• Oversee study feasibility assessments, protocol implementation, and compliance with regulatory standards (US CFR, ICH GCP, OU Health policies).

• Develop and maintain Standard Operating Procedures (SOPs) to support consistent and compliant research practices.

• Design and execute patient recruitment strategies to support enrollment goals across clinical trials.

• Lead and manage clinical research operations, including staffing, training, workflow coordination, and performance oversight.

• Provide continuing education and professional development opportunities for research staff.

• Manage departmental financial processes, including budget development, sponsor negotiations, and resource allocation.

• Collaborate with sponsors, Institutional Review Boards (IRBs), and research faculty to resolve regulatory and operational challenges.

• Serve as a backup research coordinator and vision examiner as needed.

General Responsibilities

• Performs other duties as assigned.

Education Requirements

• Bachelor’s Degree required.

Experience Requirements

• 3 to 5 years of progressive leadership experience required, with experience, in an inpatient or outpatient clinic.

License/Certification/Registration Requirements

• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification required.

Knowledge/Skills/Abilities

• Comprehensive knowledge of clinical research operations, including protocol development, regulatory compliance, and study execution.

• Understanding of federal regulations and international standards, including US CFR, ICH GCP, and IRB requirements.

• Skill in managing research staff, including hiring, training, scheduling, and performance evaluation.

• Ability to oversee financial processes, including budget development, sponsor negotiations, and resource allocation.

• Strong leadership and problem-solving skills to resolve operational and regulatory challenges.

• Effective communication and collaboration abilities for working with investigators, sponsors, and regulatory bodies.

• Proficiency in developing SOPs and implementing quality improvement initiatives.

• Ability to design and execute patient recruitment strategies to meet enrollment targets.

• Commitment to staff development, including continuing education and mentoring.

• Strategic thinking and judgment to align research operations with institutional goals.

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OU Health is an equal opportunity employer. We offer a comprehensive benefits package, including PTO, 401(k), medical and dental plans, and many more. We know that a total benefits and compensation package, designed to meet your specific needs both inside and outside of the work environment, create peace of mind for you and your family.