Regulatory & Compliance Specialist I

1 month ago


Worcester Massachusetts, United States University of Massachusetts Medical School Full time
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:

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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