UMass Chan Medical School · 7 hours ago
Sr. Protocol Specialist
Worcester, MA
Full-time
Onsite
Mid, Senior Level
4+ years expUMass Chan Medical School is seeking a Senior Protocol Specialist to ensure efficient and effective research compliance with institutional, state, and federal policies and regulations. The role involves directing protocol design, conducting training programs, and leading compliance efforts to maintain high standards in research protocols.
EducationHigher EducationMedical
Responsibilities
Direct protocol design, document control, and protocol compliance with NIH and Federal regulations
Ensure that protocols, forms, and other documents are developed in compliance with guidelines related to Good Clinical Practice, Standard Operating Practices (SOP), and that data collection plans are consistent with regulatory requirements and the protocol objectives
Determine the need for and prepare technical and administrative guides, standards, manuals, reports, and criteria related to accomplishing objectives
Assist the director with the communication of stipulations that have been designated in the review process and/or counsel the investigator on how to improve the protocol application and resubmit it in a more appropriate form
Collaborate with staff on issues within the purview of protocol design. Participate as an expert at meetings, conferences, and symposia
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
Develop priorities, policies, and define associated requirements for oversight of protocols. Design and conduct assessments of performance with respect to the achievement of program goals and objectives. Prepare plans and recommendations for any identified necessary changes
Responsible for the operational support for activities for a protocol or group of protocols
Prepare data and report on special projects. Assist with communications to internal and external agencies/committees
Assign and/or conduct comprehensive and timely review of all new submissions before Committee assignment, ensuring consistency between submission and related protocol
Lead Protocol and Regulatory Specialists, ensuring the flow of work and act in the role of content expert on protocols development
Ensure each new submission is reviewed for completeness and conformance with established university, federal and state regulations. Provide instruction and advice to researchers and specialists on regulations and preparation of applications
Process expedited reviews
Ensure protocol review process follows quality and quantity expectations. Update and redesign the process to accommodate organizational changing needs
Schedule and conduct semiannual inspections and program review; following up with deficiencies and preparing reports
Serve as consultant to members, investigators and key personnel on matters related to protocol procedures
Follow-up on late and incomplete submissions with investigators and key personnel
Organize and prepare meeting agendas and assign appropriate Committee members as primary reviewers of submissions
Respond to Committee requests and special monitoring requirements as directed by Chair, Director or Manager
Maintain current understanding and knowledge of federal and state regulations, state and local laws
Monitor, evaluate and update procedures
Evaluate protocol Amendments and animal reviews; determine accuracy and completeness, request additional material or information in order to address concerns
Perform related duties as required
Qualification
Required
Bachelor's degree in biological sciences or equivalent experience
4 years of scientific research related experience with 2 years in a scientific administration role
Knowledge of federal regulations pertaining to research and hazardous biological materials (e.g., NIH Guidelines for synthetic and recombinant nucleic acids, Biosafety in Microbiological and Biomedical Laboratories 5th edition)
Ability to educate and conduct training sessions both on individual and group level
Strong knowledge of Microsoft Word, Access, and Excel
Strong knowledge of protocol processes and approval mechanisms included in ongoing oversight
Requires organizational and interpersonal skills, attention to detail, and effective oral and written communication skills necessary to interact with all levels of personnel, both within and outside UMass Worcester
Experience in handling complex and confidential material
Ability to prioritize, problem solve, and work under pressure in a deadline oriented environment
Company
UMass Chan Medical School
Massachusetts’ first and only public academic health sciences center is made up of three graduate schools.
5001-10000 employees
Funding
Current Stage
Late StageTotal Funding
$13.6MKey Investors
Centers for Disease Control and PreventionCommonwealth of Massachusetts
2025-11-18Grant· $2M
2024-04-03Grant· $11.6M
Leadership Team
M
Marc Uknis
Adjunct Associate Professor Of Surgery, Microbiology & Applied Physiology
Michael Collins
Chancellor
Recent News
2026-02-04
2026-01-18
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