Job Description

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).

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.

Minimum Education Required

Bachelor's degree or equivalent experience.

Preferred Education

Advanced degree in relevant field may be desirable.

Experience Required

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

Preferred Experience

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.

Requires successful completion of a background check. Selected candidate may be requested to complete a pre-employment physical including a drug screen.

FUNCTION/SUBFUNCTION: Research Administration/Research Compliance

CAREER BAND: Specialized- Individual Contributor

CAREER LEVEL: S4

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