IRB Analyst

GENERAL SUMMARY OF POSITION: 

Under the direction of the Director or designee, the Internal Review Board (IRB) Analyst reviews IRB submissions ensuring efficient and effective research compliance with institutional, state and federal policies and regulations. The IRB Analyst 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:

• Perform screening/review of submissions to ensure completeness and conformance with established university, federal, and state regulations.
• Educate and advise investigators and key personnel in response to submissions; recommend adaptations to ensure adequacy & completeness.
• Conduct comprehensive and timely review of submissions eligible for Non-Committee review.
• Provide comprehensive and timely processing of submissions requiring Committee review.
• Organize and prepare meeting agendas and assign appropriate Committee members as reviewers; attend all Committee meetings and prepare minutes in a timely fashion.
• Provide instruction and advice to researchers on regulations and preparation of applications.
• Serve as consultant to members, investigators, and key personnel on matters related to human subject protections.
• Respond to Committee requests and special monitoring requirements as directed.
• Assess educational needs of constituency. Design training programs and conduct individual and/or group training sessions.
• Assist in preparing for inspections and program review, following up with deficiencies and preparing reports.
• Assist in monitoring, evaluating, and updating procedures.
• 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.
• Maintain detailed and complete records.
• Maintain understanding and knowledge of current federal and state regulations and local laws.
• Adhere to requirements of Human Research Protection Program.
• Perform other duties as required.

REQUIRED QUALIFICATIONS:

• Bachelor’s degree in a scientific or health care field, or equivalent experience
• 4 years of experience in human subjects IRB administration or related experience
• Strong knowledge of federal regulations pertaining to research
• Strong knowledge of IRB processes and approval mechanisms included in ongoing IRB oversight
• Knowledge of clinical research and familiarity with medical terminology
• Certification as IRB Professional (CIP) or equivalent
• Experience educating and conducting training sessions both on individual and group level
• Strong knowledge of Microsoft Word and Excel
• Strong 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:

Master’s degree or higher in a relevant field

** This is a Hybrid position**

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