Regulatory Relations Specialist jobs in Fitchburg, MA

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.

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.

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 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.