Clinical Research Manager - CCC | Clinical Trials Office

Position Summary

Clinical Research Manager who will manage, develop and oversee the conduct of non-therapeutic clinical trials within OSUCCC Clinical Trials Office (CTO) under direction of the Assistant Director of Non-Therapeutics and the Clinical Trials Director.

Responsibilities

Oversees planning, organization, implementation and execution of all non-therapeutic clinical research projects

Manages and supervises daily administrative, operational, research and patient care activities collaborating and communicating with faculty, administration, research staff and shared resources within James Cancer Hospital and OSUCCC as appropriate

Plans, directs, assigns and monitors team workflow, activities and productivity to ensure fulfillment of research goals

Communicates and collaborates with disease-specific Clinical Research Managers in order to coordinate clinic activity and staff oversight

Collaborates with the Assistant Director of Non-Therapeutics and Clinical Trials Director in hiring, supervising, training, scheduling and evaluating research personnel

Directly manages non-therapeutic research staff both remotely and in clinic

Develops and implements plans to meet requirements of new studies / protocols and ensures all requirements are met

Plans and leads non-therapeutic team meetings at which protocol activity and progress, resource allocations and productivity benchmarks are reviewed; provides feasibility assessments

Conducts quality assurance reviews of research processes and data

Collaborates with OSUCCC investigators and regulatory staff in the development, review, submission and implementation of research protocols

On a limited level, collaborates with the Assistant Director of Non-Therapeutics and principal investigator (PI) to develop, negotiate, implement and administer research study budgets

Reviews, monitors and approves expenditures to ensure appropriateness; manages and supervises recruitment, interviews, screening and enrolling of patients into research protocols

Develops, implements and oversees education of patients participating in study

Ensures appropriate patient care and follow-up according to protocol

Participates in writing and submission of manuscripts.

Assists in the operations of the Recruitment, Intervention and Survey Shared Resource (RISSR) within the Comprehensive Cancer Center.

Directly supports projects and investigators utilizing RISSR with protocol development, revisions, document creation, study design, study start-up, and logistics

Manages and serves as liaison to collaborative research projects internal and external to OSU

Assists with regulatory compliance and submissions to the Institutional Review Board at OSU and other / external boards, amendments, and responses as needed

Job Requirements

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 experience in a clinical research capacity conducting amp; implementing research projects required; experience in a progressively responsible administrative or management research capacity preferred; knowledge of clinical research regulations, guidelines amp; compliance issues required including Institutional Review Board (IRB) amp; federal or industry sponsor processes and requirements; ACRP (Assn of Clinical Research Professionals) or SOCRA (Society of Clinical Research Associates) certification required; supervisory experience preferred; knowledge of clinical trials data management preferred.

Research and Scholarship - Clinical Research - People Leader - Managerial - M2 Manager

As one of only 50 designated comprehensive cancer centers in the nation, The Ohio State University Comprehensive Cancer Center Arthur G. James Cancer Hospital and Richard J. Solove Research Institute is dedicated to the creation of knowledge in laboratory, clinical and population-based cancer research. We apply those discoveries to develop more effective approaches to cancer prevention, diagnosis, and therapies providing tomorrows standard of care today. A Cancer-Free World Begins Here.