Ohio State University Wexner Medical Center
Lead Clinical Research Specialist
Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43224
Lead Clinical Research Specialist responsible for startup activities for all behavioral, epidemiological, and non-therapeutic clinical trials within the Recruitment, Intervention and Survey Shared Resource (RISSR) under direction of RISSRs technical and administrative Director.ResponsibilitiesManages and monitors 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
Oversees planning, organization, and implementation of all research projects
Collaborates with OSUCCC investigators in the finalization of protocols, informed consents and case report forms
Develops and implements plans to meet requirements of new studies/protocols and ensures all requirements are met
Plans and leads budget and regulatory meetings at which protocol activity and progress, resource allocations and productivity benchmarks are reviewed
Collaborates with OSUCCC investigators and regulatory staff in the development, review, submission, and implementation of research protocols
Collaborates with investigators and Clinical Research Finance and Compliance (CRFC) to develop, negotiate, implement, and administer research study budgets
Plans, directs, assigns, and monitors team workflow, activities, and productivity to ensure fulfillment of research goals
Conducts quality assurance reviews of research processes and data
Minimum Required QualificationsBachelors Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; 5 years of relevant experience required; experience in a progressively responsible administrative or management research capacity preferred; knowledge of clinical research regulations, guidelines and compliance issues required including Institutional Review Board (IRB) and federal or industry sponsor processes and requirements; ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required; knowledge of clinical trials data management preferred.
Oversees planning, organization, and implementation of all research projects
Collaborates with OSUCCC investigators in the finalization of protocols, informed consents and case report forms
Develops and implements plans to meet requirements of new studies/protocols and ensures all requirements are met
Plans and leads budget and regulatory meetings at which protocol activity and progress, resource allocations and productivity benchmarks are reviewed
Collaborates with OSUCCC investigators and regulatory staff in the development, review, submission, and implementation of research protocols
Collaborates with investigators and Clinical Research Finance and Compliance (CRFC) to develop, negotiate, implement, and administer research study budgets
Plans, directs, assigns, and monitors team workflow, activities, and productivity to ensure fulfillment of research goals
Conducts quality assurance reviews of research processes and data
Minimum Required QualificationsBachelors Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required; 5 years of relevant experience required; experience in a progressively responsible administrative or management research capacity preferred; knowledge of clinical research regulations, guidelines and compliance issues required including Institutional Review Board (IRB) and federal or industry sponsor processes and requirements; ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required; knowledge of clinical trials data management preferred.