Regulatory & Compliance Specialist I
1 month ago
POSITION SUMMARY:
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.
Responsibilities:
ESSENTIAL DUTIES:
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.
Qualifications:
REQUIRED QUALIFICATIONS:
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
Preferred Qualifications:
Experience in Institutional Animal Care and Use Committee (IACUC) administration.
Knowledge of regulations/guidelines pertaining to IACUC and animal care/use.
Additional Information:
Preferred Qualifications and Experience for IACUC Regulatory Specialist I:
Experience in Institutional Animal Care and Use Committee (IACUC) administration.
Knowledge of regulations/guidelines pertaining to IACUC and animal care/use.
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