Lead Clinical Research Specialist

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.

Responsibilities

• Manages 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 Qualifications

Bachelors 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.