Clinical Research Compliance Analyst

Under the general direction of the Associate Director of Clinical Research Compliance or designee, the Clinical Research Compliance Analyst ensures the institution's compliance with all assigned clinical research regulatory policies and procedures.

Responsibilities

• Draft, negotiate, and manage a variety of clinical research contracts in a timely manner.
• Ensure timely completion of information in relevant contract management tools/tracking systems.
• Collaborate with other internal contracting departments when triaging agreements to facilitate appropriate review.
• Implement and monitor compliance program components (such as AAHRPP accreditations, ClinicalTrials.gov, etc.).
• Assist with the identification, interpretation, implementation, and maintenance of relevant federal and state regulations and local policies.
• Prepare and assist with implementing remediation and corrective action plans, audit responses, and timelines.
• Coordinate with staff members to address compliance program matters.
• Assist with the development, review, and revision of assigned curriculum, training materials, job aids, SOPs, and policies.
• Deliver compliance training and orientation to clinical research staff/faculty.
• Collaborate with staff to ensure related web page content is written and maintained.
• Maintain various internal reporting systems, providing metrics to senior management to ensure accuracy and timeliness.
• Perform other duties as required.

Responsibilities (Level II)

• Provide expert knowledge and guidance on relevant federal, state, and institutional regulations governing clinical research (e.g., FDA, OHRP, IRB, IBC).
• Prepare and coordinate regulatory submissions, such as INDs, IND amendments, annual reports, and agency meeting packages, in collaboration with faculty and staff.
• Serve as primary or backup institutional ClinicalTrials.gov PRS administrator, ensuring accurate registration and results reporting.
• Monitor, identify, and interpret ongoing regulatory requirements and changes in guidance, implementing and maintaining institutional policies and compliance practices.
• Create all shell records within the eReg electronic document management system, ensuring integration with the corresponding record in the OnCore CTMS.
• Maintain all site/central information in the eREG system, ensuring rosters, lab normals, and UMass-specific data are entered in a timely manner.
• Serve as a clinical research regulatory and compliance subject matter expert for investigators and study team members.
• Collaborate with CCTS and other internal stakeholders on assessment, development, and maintenance of Standard Operating Procedures, guidance documents, and job aids, including those related to Good Clinical Practice.
• Work closely with CCTS/ORC billing and coverage analysts to ensure regulatory compliance with federal clinical research billing requirements.
• Participate in and support compliance program components such as AAHRPP accreditation, internal audits, and quality assurance reviews, identifying trends and preparing corrective action plans as needed.
• Deliver compliance and regulatory training sessions to clinical research staff and faculty and assist with curriculum and job aid development.
• Create content for the UMass Chan ConqueringDiseases.org recruitment site, working closely with OCR and IT to ensure integration between the CTMS system and ConqueringDiseases.org functions as expected.
• Ensure all IRB and regulatory requirements supporting ConqueringDiseases.org are maintained and kept current.
• Provide guidance and consultative support for compliance-related inquiries from research teams.
• Coordinate with IRB, IBC, contracts, and other regulatory bodies or internal departments for triage and review of regulatory submissions.
• Maintain internal reporting systems, compile compliance metrics for management, and support regulatory office hours and special projects as assigned.

Requirements

Clinical Research Compliance Analyst

• Bachelor's Degree in a related field, or equivalent experience.
• 2-3 years of experience drafting and negotiating contracts/agreements related to the biomedical/science industry and analyzing clinical research compliance/regulatory component areas.
• Working knowledge and understanding of federal, state regulations, and guidance related to clinical research.
• Strong computer and software skills.

Clinical Research Compliance Analyst II

• Bachelor’s Degree in a related field, or equivalent experience.
• 3–4 years of experience managing clinical research compliance/regulatory areas.
• Demonstrated working knowledge and understanding of federal and state regulations and guidance related to clinical research.
• Strong computer and software skills.

Preferred Qualifications

Clinical Research Compliance Analyst

• Certification in clinical research (CIP, SOCRA, ACRP, or equivalent).
• Prior experience in an academic health center or hospital.
• OnCore clinical trial management experience.

Clinical Research Compliance Analyst II

• OnCore CTMS & Advarra eREG experience strongly preferred.
• Experience working with FDA-regulated clinical trial protocols preferred.
• Certification in clinical research (CIP, SOCRA, ACRP, or equivalent).
• OnCore Financial and Management Certifications preferred.

Schedule

This is a hybrid work model with the understanding that the Analyst will be available and onsite as required to support the department.