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The University of Massachusetts Medical School (UMASS Medical) is a group of diverse businesses that make a significant contribution and impact in higher education, medical research, healthcare consulting/delivery and biotechnology throughout the commonwealth and the world. 

We were recognized by US News & World Report Rankings as one of the best graduate schools for Primary Care Education and rank in the top 10 percent in the nation!  At UMass Medical School, Commonwealth Medicine and MassBiologics, our commitment to excellence, diversity, competitive salary & benefits.  Work-life integration will allow you to build a professionally rewarding career as we work together to positively impact the health of people around the globe.

GENERAL SUMMARY OF POSITION:

Under the general supervision of the IRB Manager develops primary role as protocol reviewer and analyst to ensure efficient and effective research compliance with institutional state and federal policies and regulations. The Protocol Specialist takes a proactive role in defining evaluating and conducting education and training programs related to IRB procedures and related regulations and federal guidance.

MAJOR RESPONSIBILITIES:

• Participate 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.
• Utilize administration system to develop tools and content to foster accurate and efficient processing.  Serve as liaison with vendor, train staff, maintain storage and retrieval of information, create templates, generate communication notifications, prepare audit tracking, and design reports. 
• As assigned by Director or Manager, conduct comprehensive and timely review of all new submissions before Committee assignment, ensuring consistency between submission and related Protocol
• Perform screening/review of each new submission to ensure completeness and conformance with established university, federal and state regulations.  Provide instruction and advice to researchers on regulations and preparation of applications. 
• In collaboration with Director or Manager, facilitate ‘expedited review’ process by communicating with investigators and key personnel
• Assess educational needs of constituency.  Design training programs and conduct individual and/or group training session.   Including training needs of committee members and conduct update sessions monthly at committee meetings in collaboration with Director or Manager
• Serve as consultant to members, investigators and key personnel on matters related to protocol procedures.
• Educate and advise investigators and key personnel in response to submissions; recommend adaptations to ensure adequacy & completeness
• 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.  Attend all department meetings and prepare minutes in absence of Director or Manager. 
• Work with Director or Manager, Coordinator and staff to maintain detailed and complete records, ensuring that all post-approval documents are consistent with original submission and ongoing amendments
• 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 in collaboration with Director,  Manager, Coordinator and office staff
• Evaluate ‘Continuing Review’ submissions responses determining accuracy and completeness, request additional material or information in order to address concerns.  Submit to committee for review.
• Evaluate protocol Amendments and animal reviews; determine accuracy and completeness, request additional  material or information in order to address concerns
• Review grant proposals with fundable priority scores to ensure that the animal experiments proposed are approved by the prior to accepting funding
• Assist the Director or Manager in scheduling and conducting semiannual inspections and program review; following up with deficiencies and preparing reports
• Perform related duties as required.

ADDITIONAL RESPONSIBILITIES (IRB):

• Monitor, evaluate and update IRB procedures in collaboration with IRB Manager, Coordinator and office staff
• Evaluate ‘Continuing Review’ submissions responses determining accuracy and completeness, request additional material or information in order to address concerns.  Submit to committee for review.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in a scientific or health care field, or equivalent experience
• 3 years of scientific research related experience
• 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
• Appropriate professional certification, or equivalent, preferred
• 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

PREFERRED QUALIFICATIONS:

• Experience in human subjects IRB administration role preferred
• Knowledge of clinical research and familiarity with medical terminology

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