Regulatory & Compliance Specialist I

University Of Massachusetts Medical School Worcester , MA 01601

Posted 2 months 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:

  • 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

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Regulatory & Compliance Specialist I

University Of Massachusetts Medical School