Regulatory & Compliance Specialist I

4 weeks ago


Worcester, 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:

  • 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.
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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