Program Coordinator - CCC | Clinical Trials Office

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Job Title:
Program Coordinator - CCC | Clinical Trials Office

Department:
CCC | Clinical Trials Office

Position Summary

The Program Coordinator will work under the supervision of the Clinical Research Training Manager to serve as a resource to promote and ensure legally compliant and ethical research practices within the Clinical Trials Office (CTO) and Comprehensive Cancer Center (CCC) by developing, coordinating, managing and presenting trainings related to the conduct of clinical research, including the Food and Drug Administration (FDA) Regulations, International Council for Harmonization (ICH) Guidelines, the National Cancer Institute (NCI) requirements for Comprehensive Cancer Center accreditation, and other federal, state, and local regulations, processes, and policies.

Responsibilities

• Knowledgeable about current research related regulations, laws, guidelines, policies, and procedures.

• Collaborate with the CTO Training Manager and Assistant Director of Operations to assist with updating the CTO research related trainings-and other documents accordingly.

• Independently present trainings on multiple general research topics including how to conduct clinical research with human participants, documentation and collection of research data, and ethical conduct of clinical research amongst others. Training will be presented to CTO research teams and positions within the CCC.

• Assist with providing training on multiple software systems to both internal team members and external monitors (study sponsor) and auditors (FDA, NCI, etc.).

• Assist with tracking the completion of the required trainings before access to these systems is granted in compliance with FDA regulations. Will be responsible for organizing, collaborating, and presenting at the CTO PI Orientation which provides training to new physicians on the CTO organization and various clinical research concepts, regulations, processes, policies, guidelines, and procedures.

• Assist with the development of assessments and assignments to ensure comprehension of research related concepts, FDA regulations, ICH guidelines, and NCI Requirements and other federal state, and local regulations, processes, and policies.

• Review assessments and assignments to provide direct feedback and guidance to research staff, and to assess if further individualized training is needed.

• Develop ongoing relationships with the CTO Staff and managers to assess if further individualized training is needed and to ensure initial onboarding is successful.

• Assist with coordinating all aspects of the CTO training sessions including registrations, invitations, attendance tracking, and preparing training documents.

• Facilitate key aspects of staff onboarding. 

• Works to maintain an accurate CTO Staff Database in RedCap and is responsible for facilitating key aspects of the onboarding and offboarding process within the CTO.

• Assists with management of the CTO Cancer-Clinical Trials and Education and Training SharePoint

• Act as a communication center to inform and assist staff on navigating CTO processes, resources, and other research related updates.

Job Requirements
Bachelor’s Degree or equivalent combination of education and experience required. One year of experience in a clinical research capacity is required.

Knowledge of good clinical practice guidelines and federal regulations strongly preferred; computer literacy required with knowledge of Microsoft Office software applications strongly preferred; clinical research certification from SOCRA or ACRP desired; and experience in presenting training programs desired.

Additional Information:

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 tomorrow’s standard of care today.  A Cancer-Free World Begins Here. 

Research Administration / Research Compliance - Individual Contributor - Specialized - S2 Experienced

Location:
Optometry Clinic (1041)

Position Type:
Regular

Scheduled Hours:
40

Shift:
First Shift

Final candidates are subject to successful completion of a background check.  A drug screen or physical may be required during the post offer process.

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The university is an equal opportunity employer, including veterans and disability.