Regulatory & Compliance Specialist I
4 weeks ago
Overview:
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:
- Bachelors 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.
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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