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Clinical Research Operations Manager
2 months ago
Join our team as a Clinical Research Operations Manager at The Ohio State University and Wexner Medical Center. As a key member of our research team, you will be responsible for overseeing the execution of clinical research operations in the College of Medicine (COM) Center for Clinical Research Management (CCRM).
Key Responsibilities:- Oversee multiple study teams and research groups, developing and implementing plans to meet the requirements of new studies.
- Recruit, hire, train, evaluate, and directly supervise disease team research managers, specialized staff, lab personnel, and other clinical research staff, as needed.
- Develop onboarding and training materials for newly hired research staff and investigators to ensure compliance with university policies and national and international research standards of conduct.
- Develop and implement new research strategies, policies, guidance, Standard Operating Procedures (SOPs), and workflows to promote adherence to institutional, national, and international research regulations/guidance for CCRM affiliated disease teams.
- Drive study start-up processes and provide solutions for overcoming barriers to study implementation.
- Contribute to College of Medicine research initiatives and facilitate collaboration among Centers, Departments, Divisions, and Offices within the COM and OSUWMC, as well as all other clinical research stakeholders within and external to the institution.
- Oversee the development and implementation of processes to enroll and consent patients to clinical research for CCRM affiliated groups.
- Monitor that research study deliverables are met, including but not limited to enrollment goals, data entry, IRB submissions, budget and contract processes.
- Collaborate with investigators to provide operational feedback for research protocols and assist with providing required information for the preparation of grant applications to obtain research funding.
- Participate in writing articles for publication and presentation related to the conduct of clinical research or clinical research oversight/administration.
- Conduct quality assurance reviews of research processes and data and provide guidance for corrective and preventative actions.
- Ensure compliance to federal, state, and local regulations and guidelines and serve as the main point of contact for guidance related to clinical research conduct and compliance.
- Participate in and oversee audits and inspections by research sponsors and regulatory agencies.
- Bachelor's Degree in biological sciences, health sciences, social sciences, or other medical field or equivalent experience required.
- 5 years of experience in a clinical research capacity conducting and implementing research projects required.
- Experience in a progressively responsible administrative or management research capacity required.
- Knowledge of clinical research regulations, guidelines, and compliance issues required, including Institutional Review Board (IRB) and federal or industry sponsor processes and requirements required.
- ACRP (Association of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required and must be maintained.
- Requires successful completion of a background check.
- Master's degree in biological sciences, health sciences, social sciences, or other medical field desired.
- 8-12 years of relevant experience preferred.
- Supervisory experience preferred.
- Knowledge of clinical trials data management preferred.
- Experience writing research grants and proposals strongly desired.
The Ohio State University is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability, ethnicity, gender identity or expression, genetic information, HIV/AIDS status, military status, national origin, race, religion, sex, gender, sexual orientation, pregnancy, protected veteran status, or any other basis under the law.
