- 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
- Experience in Institutional Animal Care and Use Committee (IACUC) administration.
- Knowledge of regulations/guidelines pertaining to IACUC and animal care/use.
- 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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Regulatory & Compliance Specialist I - Worcester, United States - UMass Med School
Description
Regulatory & Compliance Specialist I
Minimum Salary
US-MA-Worcester
Job Location
19 hours ago(5/2/2024 10:46 AM)
Requisition Number
# of Openings
1
Posted Date
Day
Shift
Exempt
Exempt/Non-Exempt Status
Non Union Position -W60- Non Unit Professional
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
Qualifications
REQUIRED QUALIFICATIONS:
Preferred Qualifications:
Additional Information
Preferred Qualifications and Experience for IACUC Regulatory Specialist I: