Hybrid Clinical Research Compliance Specialist

UMass Chan Medical School; Worcester (MA); Hybrid; USD 85,000 - 110,000; Full time

Job summary

UMass Chan Medical School in Worcester, MA seeks a Clinical Research Compliance Analyst to ensure adherence to federal, state, and institutional regulations governing biomedical research. Under the Assoc Director of Clinical Research Compliance, the role drafts contracts, tracks submissions, and supports policy development.

The candidate collaborates with CCTS/ORC/IRB teams, maintains content in regulatory systems, and assists with remediation plans and AAHRPP activities.

Qualifications

• Bachelor's degree or equivalent experience.
• 2–3 years of experience drafting and negotiating contracts related to biomedical/science industry.
• Working knowledge of federal, state regulation and guidance related to clinical research.
• Strong computer and software skills.

Responsibilities

• Draft, negotiate and manage a variety of clinical research contracts in a timely manner.
• Ensure timely completion of information in contract management tools/TRacking systems.
• Collaborate with other internal contracting departments when triaging agreements for review.
• Implement and monitor compliance program components (AAHRPP, clinicaltrials.gov).
• Assist with identification and interpretation of federal/state regulations and local policies.
• Prepare and assist with remediation and corrective action plans and audit responses.

Skills

Contract drafting & negotiation

Regulatory compliance

Documentation & recordkeeping

Communication & collaboration

Education

Bachelor's degree in a related field

Tools

OnCore CTMS

eReg system

Regulatory databases

Job description

UMass Chan Medical School in Worcester, MA seeks a Clinical Research Compliance Analyst to ensure adherence to federal, state, and institutional regulations governing biomedical research. Under the Assoc Director of Clinical Research Compliance, the role drafts contracts, tracks submissions, and supports policy development.

The candidate collaborates with CCTS/ORC/IRB teams, maintains content in regulatory systems, and assists with remediation plans and AAHRPP activities.