Clinical Research Compliance Analyst - Open Rank

University of Massachusetts Medical School•Worcester, MA

11h•Hybrid

About The Position

Under the general direction of the Assoc Director of Clinical Research Compliance or designee, the Clinical Research Compliance Analyst is responsible for ensuring the institutions compliance with all assigned clinical research regulatory policies and procedures. The Clinical Research Compliance Analyst II provides expert knowledge of and guidance on relevant federal, state, and institutional regulations governing clinical research (e.g., FDA, OHRP, IRB, IBC), and has demonstrated working knowledge and understanding of these regulations and guidance. Prepares and coordinates regulatory submissions, such as INDs, IND amendments, annual reports, and agency meeting packages, in collaboration with faculty and staff. Serves as primary or backup institutional clinicaltrials.gov PRS administrator, ensuring accurate registration and results reporting. Monitors, identifies, and interprets ongoing regulatory requirements and changes in guidance, implementing and maintaining institutional policies and compliance practices. Creates all shell records within the eReg electronic document management system, ensuring that shell record in integrated with the corresponding record in the OnCore CTMS. Maintains all site/central information in the eREG system ensuring rosters, lab normals and UMass specific data is entered in a timely manner. Serves as clinical research regulatory and compliance subject matter expert for investigators and study teams members Collaborates 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. Works closely with CCTS/ORC billing and coverage analysts, when necessary, to ensure regulatory compliance with federal clinical research billing requirements. Participates in and supports compliance program components such as AAHRPP accreditation, internal audits, and quality assurance reviews, identifying trends and preparing corrective action plans as needed. Delivers compliance and regulatory training sessions to clinical research staff and faculty and assists with curriculum and job aid development. Responsible for the creation of content for the UMass Chan Conqueringdiseases.org recruitment site. Working closely with OCR and IT to ensure that the integration between the CTMS system and conqueringdiseases.org is functioning a expected. Ensures that all IRB and regulatory requirements supporting conqueringdiseases.org is maintained and kept current. Provides guidance and consultative support for compliance-related inquiries from research teams, supported by strong computer and software skills. Coordinates with IRB, IBC, contracts, and other regulatory bodies or internal departments for triage and review of regulatory submissions. Maintains internal reporting systems, compiles compliance metrics for management, and supports regulatory office hours and special projects as assigned.

Requirements

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

Nice To Haves

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

Responsibilities

Responsible for drafting, negotiating and managing a variety of clinical research contracts in a timely manner
Ensure timely completion of information in relevant contract management tool/tracking systems
Collaborate with other internal contracting department when triaging agreements to facilitate appropriate review
Implement and monitor compliance program components (such as AAHRPP accreditations, clinical trials.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 when needed to address compliance program matters
Assist with the development, review, and revise assigned curriculum, training materials, job aids, SOPs, and policies
Deliver compliance training and orientation to clinical research staff/faculty
Collaborate with staff to ensure that related web page content is written and maintained
Maintain various internal reporting systems, providing metrics to senior management ensuring that metrics are captured in an accurate and timely manner
Perform other duties as required.
Prepares and coordinates regulatory submissions, such as INDs, IND amendments, annual reports, and agency meeting packages, in collaboration with faculty and staff.
Serves as primary or backup institutional clinicaltrials.gov PRS administrator, ensuring accurate registration and results reporting.
Monitors, identifies, and interprets ongoing regulatory requirements and changes in guidance, implementing and maintaining institutional policies and compliance practices.
Creates all shell records within the eReg electronic document management system, ensuring that shell record in integrated with the corresponding record in the OnCore CTMS.
Maintains all site/central information in the eREG system ensuring rosters, lab normals and UMass specific data is entered in a timely manner.
Serves as clinical research regulatory and compliance subject matter expert for investigators and study teams members
Collaborates 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.
Works closely with CCTS/ORC billing and coverage analysts, when necessary, to ensure regulatory compliance with federal clinical research billing requirements.
Participates in and supports compliance program components such as AAHRPP accreditation, internal audits, and quality assurance reviews, identifying trends and preparing corrective action plans as needed.
Delivers compliance and regulatory training sessions to clinical research staff and faculty and assists with curriculum and job aid development.
Responsible for the creation of content for the UMass Chan Conqueringdiseases.org recruitment site.
Working closely with OCR and IT to ensure that the integration between the CTMS system and conqueringdiseases.org is functioning a expected.
Ensures that all IRB and regulatory requirements supporting conqueringdiseases.org is maintained and kept current.
Provides guidance and consultative support for compliance-related inquiries from research teams, supported by strong computer and software skills.
Coordinates with IRB, IBC, contracts, and other regulatory bodies or internal departments for triage and review of regulatory submissions.
Maintains internal reporting systems, compiles compliance metrics for management, and supports regulatory office hours and special projects as assigned.