Research Compliance Consultant, CCRM

The Ohio State University

3d • Remote

About The Position

The Research Complianc Consultant (Research Compliance Analyst 4) serves as primary resource in regulatory aspects by providing regulatory expertise to ensure research protocols are following university, state and federal regulations across research groups managed by the College of Medicine (COM) Center for Clinical Research Management (CCRM).

Requirements

• Minimum Education Required Bachelor's degree or equivalent experience.
• 6 years of relevant experience required.
• Knowledge of clinical research regulations and compliance issues especially related to the use of human and animal subjects required
• Requires successful completion of a background check.
• Selected candidate may be requested to complete a pre-employment physical including a drug screen.

Nice To Haves

• Advanced degree in relevant field may be desirable.
• 8-12 years of relevant experience preferred.
• Experience and knowledge of federal & industry research sponsor requirements preferred; experience in a regulatory affairs capacity in a medical or research setting desired; experience in protocol development desired.

Responsibilities

• Assists CCRM Regulatory Leadership with the daily oversight of the Regulatory team and monitoring of the regulatory research compliance functions across all research sections/disease groups managed by the CCRM.
• Participates in interviews for regulatory staff and trains, mentors, and assists with supervising staff.
• Serves as the subject matter expert for all regulatory compliance officers within the CCRM by monitoring & ensuring compliance with Institutional Review Boards (IRBs), FDA (Federal Drug Administration), federal, state & industry sponsor regulations.
• Answers questions and provides technical support to junior members on the CCRM Regulatory team.
• Provides coverage/back up as needed for Assistant Director, Regulatory Manager and/or team members.
• Performs quality checks of CCRM regulatory files.
• Participates in the development of SOPs and processes for the CCRM Regulatory team to stay current with the changing regulatory requirements and training.
• Participates in the creation and delivery of onboarding and educational training programs, tools and materials for CCRM staff and investigators.
• Provides regulatory guidance, direction and support to all members of research teams.
• Stays current on legislation, rules, regulations, procedures, and development; educates physicians and staff regarding changes related to clinical research protocols, university staff, affiliates, and subjects.
• Work with CCRM Operations Managers and coordinators as needed to ensure understanding of regulatory processes.

Benefits

• Medical, dental and vision coverage, with Ohio State paying a significant portion of the cost.
• Paid time off, including sick and vacation time and 11 holidays.
• State retirement plan or an alternative retirement plan, both with generous employer contributions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees