Regulatory & Compliance Spec I

Job Description



Under the direction of the Director or designee, the Regulatory and Compliance Specialist I is responsible for ensuring research regulatory affairs and compliance with federal and state regulations and institutional policies and procedures.



-Gather data, review, and triage the submissions of various initial and continuing review requests ensuring accuracy and the appropriate level of review according to the state and federal regulations

-Assess submissions for consistency with regulation & compliance requirements

-Track the metrics of the performance of processes (initial, continuing review, new information reporting, etc) as well as responses from investigators and research staff for resolution

-Ensure that delegated pre-review process communications for investigators are handled efficiently

-Prepare, review, and submit regulatory and compliance documents

-Coordinate training to the research community

-Coordinate central committee communication for meetings, agendas, approvals, etc.

-Provide support for all web changes and enhancements of information

-Compile data and assist in designing reports for internal and external audiences

-Prepare, maintain and revise procedures or instruction manuals, and integrate changes

-Perform other duties as required.



-Bachelor’s degree in science, a related field, or equivalent experience

-1-3 years of experience in research or regulatory/compliance administration or other relevant experience

-Experience in handling confidential and sensitive material

-Effective oral and written communication skills

-Ability to prioritize, problem-solve and work under pressure in a deadline-driven environment

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