Clinical Research Manager
4 weeks ago
As the Clinical Research Manager at the Ohio State University Wexner Medical Center, you will play a critical role in the startup activities for all behavioral, epidemiological, and non-therapeutic clinical trials within the Recruitment, Intervention and Survey Shared Resource (RISSR). Reporting to the RISSR's technical and administrative Director, you will be responsible for managing and monitoring administrative, operational, and research activities within RISSR, engaging with investigators, RISSR staff, research staff, and collaborating teams within James Cancer Hospital and OSUCCC as appropriate.
Key Responsibilities
- Manage and monitor administrative, operational, and research activities within RISSR, ensuring seamless collaboration with investigators, RISSR staff, research staff, and collaborating teams.
- Oversee the planning, organization, and implementation of all research projects, ensuring timely completion and adherence to regulatory requirements.
- Collaborate with OSUCCC investigators in the finalization of protocols, informed consents, and case report forms, ensuring compliance with regulatory standards.
- Develop and implement plans to meet requirements of new studies/protocols, ensuring all requirements are met and research goals are achieved.
- Plan and lead budget and regulatory meetings, reviewing protocol activity and progress, resource allocations, and productivity benchmarks.
- Collaborate with OSUCCC investigators and regulatory staff in the development, review, submission, and implementation of research protocols, ensuring compliance with regulatory requirements.
- Collaborate with investigators and Clinical Research Finance and Compliance (CRFC) to develop, negotiate, implement, and administer research study budgets, ensuring fiscal responsibility and compliance.
- Plan, direct, assign, and monitor team workflow, activities, and productivity to ensure fulfillment of research goals, promoting a culture of excellence and collaboration.
- Conduct quality assurance reviews of research processes and data, ensuring accuracy, integrity, and compliance with regulatory standards.
Minimum Required Qualifications
A Bachelor's Degree in biological sciences, health sciences, social sciences, or other medical field, or an equivalent combination of education and experience, is required. Five years of relevant experience is required, with experience in a progressively responsible administrative or management research capacity preferred. Knowledge of clinical research regulations, guidelines, and compliance issues, including Institutional Review Board (IRB) and federal or industry sponsor processes and requirements, is required. ACRP (Association of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification is required. Knowledge of clinical trials data management is preferred.
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