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Regulatory & Compliance Specialist - Open Rank
Job Number: 2026-49995
Category: Research
Location: Worcester, MA
Shift: Day
Exempt/Non-Exempt: Exempt
Business Unit: UMass Chan Medical School
Department: School - Dermatology - W823000
Job Type: Full-Time
Union Code: Non Union Position -W60- Non Unit Professional
Num. Openings: 1
Post Date: June 1, 2026
Salary Minimum: USD $62,000.00/Yr.
Salary Maximum: USD $92,000.00/Yr.
Under the direction of the Director or designee, the Regulatory and Compliance Specialist is responsible for ensuring research regulatory affairs and compliance with federal and state regulations and institutional policies and procedures.
Regulatory & Compliance Specialist I:
- 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.
Regulatory & Compliance Specialist II:
- Participate in or lead special projects from concept to completion. Activities may include conducting research/collecting information, establishing project schedule, organizing team meetings, and monitoring/reporting project status
- 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
- Ensure that post- award documents are consistent with the original submission and ongoing amendments. Request additional material or information in order to address concerns
- Ensure that delegated pre-review process communication to investigators is handled efficiently
- Coordinate activities with researchers, sponsors, and regulatory/compliance agencies
- Follow up on late and/or incomplete submissions
- Facilitate the expedited review process
- Perform internal audits of research activities and investigate complaints
- Assess the educational needs of the research community, recommend training opportunities, and conduct individual and/or group training sessions
- Attend central committee meetings, coordinate activities, and respond to committee requests for special information and monitoring requirements
- Assist in preparing for inspections and program review, following up with deficiencies and preparing reports
- Interpret regulatory/compliance developments and make recommendations for changes when current business processes are impacted
- Compile and analyze data and prepare reports for internal and external audiences
- Prepare, maintain and revise research application forms, procedures or instruction manuals and integrate changes
- Perform other duties as required.
Sr Regulatory & Compl Specialist:
- Lead protocol design, document control, and protocol compliance with NIH and Federal regulations
- Ensure compliance in the submission of various initial and continuing review requests
- Recommend and implement changes when current business processes are impacted by regulatory/compliance developments
- Lead the implementation of changes to regulatory/compliance processes and documents
- Identify organizational education requirements and develop a strategy to ensure that all educational requirements are met with appropriate courses/trainings. Evaluate results, recommend improvements, and implement new course design
- Lead Regulatory and Compliance Specialists, ensuring the flow of work and act in the role of content expert on regulations, protocol, and federal and state regulations and institutional policies and procedures
- Develop priorities, policies, and define associated requirements for oversight of protocols
- Process expedited reviews
- Schedule and conduct semiannual inspections and program review
- Assess submissions for consistency with regulation & compliance requirements
- Perform internal audits of research activities, make recommendations to resolve complaints, and verify that deficiencies are corrected
- Ensure that delegated pre-review process communication to investigators is handled efficiently
- Ensure that post- award documents are consistent with the original submission and ongoing amendments. Request additional material or information in order to address concerns
- Coordinate activities with researchers, sponsors, and regulatory/compliance agencies
- Follow up on late and/or incomplete submissions
- Attend central committee meetings, coordinate activities, and respond to committee requests for special information and monitoring requirements
- Compile and analyze data and prepare reports for internal and external audiences
- Perform other duties as required.
Regulatory & Compliance Specialist I:
- Bachelors 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
Regulatory & Compliance Specialist II:
- Bachelors degree in science, a related field, or equivalent experience
- 3-5 years of experience in research or regulatory/compliance administration or other relevant areas
- 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
Sr Regulatory & Compl Specialist:
- Bachelors degree in science, a related field, or equivalent experience
- 5-7 years of experience in research or regulatory/compliance administration or other relevant areas
- 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
Posting Disclaimer:
This job posting outlines the primary responsibilities and qualifications for the role but is not intended to be an exhaustive list. Duties and expectations may evolve in response to the needs of the department and the broader institution.
In alignment with our commitment to pay transparency, the base salary range for this position is listed above (exclusive of benefits and retirement). At UMass Chan Medical School, final base salary offers are determined based on a combination of factors, including your skills, education, and relevant experience. We also consider internal equity to ensure fair and consistent compensation across our teams.
Please note that the range provided reflects the full base salary range for this position. Offers are typically made within the midrange to allow for future growth and development within the role.
In addition to base pay, UMass Chan offers a comprehensive Total Rewards package, which includes paid time off, medical, dental, and vision coverage, and participation in a 401(a)-retirement plan, with the option to contribute to a voluntary 403(b) plan.
UMass Chan welcomes all qualified applicants and complies with all state and federal anti-discrimination laws.
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