GENERAL SUMMARY OF POSITION: 

Under the direction of the Director or designee, the Senior Protocol Specialist is the senior protocol reviewer and analyst, ensuring efficient and effective research compliance with institutional, state and federal policies and regulations. The Senior Protocol Specialist defines, evaluates, and conducts education and training programs related to protocol procedures and related regulations and federal guidance.

MAJOR 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

REQUIRED QUALIFICATIONS:

• 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 5^th 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

The Sr. Protocol Specialist will conduct NIH grant to protocol congruence reviews.

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