Regulatory & Compliance Specialist - Open Rank

University of Massachusetts Medical School•Worcester, MA

11d

About The Position

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. This role involves various levels of responsibility depending on the rank, from data gathering and submission review to leading special projects, internal audits, and managing a team of specialists.

Requirements

Bachelor’s degree in science, a related field, or equivalent 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.
1-3 years of experience in research or regulatory/compliance administration (for Specialist I).
3-5 years of experience in research or regulatory/compliance administration (for Specialist II).
5-7 years of experience in research or regulatory/compliance administration (for Sr. Specialist).

Responsibilities

Gather data, review, and triage submissions for initial and continuing review requests, ensuring accuracy and appropriate review levels according to state and federal regulations.
Assess submissions for consistency with regulation and compliance requirements.
Track performance metrics of processes (initial, continuing review, new information reporting, etc.) and investigator responses.
Ensure efficient handling of delegated pre-review process communications for investigators.
Prepare, review, and submit regulatory and compliance documents.
Coordinate training for the research community.
Coordinate central committee communication for meetings, agendas, approvals, etc.
Provide support for web changes and information enhancements.
Compile data and assist in designing reports for internal and external audiences.
Prepare, maintain, and revise procedures or instruction manuals, and integrate changes.
Participate in or lead special projects from concept to completion.
Ensure post-award documents are consistent with original submissions and ongoing amendments.
Request additional material or information to address concerns.
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 educational needs of the research community, recommend training opportunities, and conduct 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 on deficiencies and preparing reports.
Interpret regulatory/compliance developments and recommend changes to business processes.
Lead protocol design, document control, and protocol compliance with NIH and Federal regulations.
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 meet them.
Evaluate results, recommend improvements, and implement new course design.
Lead Regulatory and Compliance Specialists, ensuring work flow and acting as a content expert.
Develop priorities, policies, and define requirements for oversight of protocols.
Process expedited reviews.
Schedule and conduct semiannual inspections and program review.
Make recommendations to resolve complaints and verify deficiency correction.