Senior Research Analyst for the Institutional Review Board

• Assists manager with developing annual monitoring plan to include a schedule for monitoring targeted studies.
• Coordinate, schedule and perform routine post IRB-approval monitoring or human research ensuring appropriate regulations were applied during the review of the study and that the study is conducted as approved by the IRB. Review will include but is not limited to: the informed consent and informed consent process; inclusion/exclusion criteria for enrolled participants; PI and key study personnel required training and ePIRATE profile; the conduct of the study (i.e. tests, procedures, evaluations, interviews and other interventions/interactions with the enrolled participants); regulatory records; case report forms (paper and electronic, source documents, etc); data security; investigational item(s) control log; reportable event reporting.
• Schedule and conduct a limited review of informed consent documents and the informed consent process for selected studies, inclusive of observation of the informed consent process between the study team and a participant.
• Perform review of UMCIRB files for selected studies ensuring UMCIRB operations follow ever more complex federal, state, and local regulations regarding the activities of the IRB.
• Develop training materials for investigators based on institutional policies, state laws, and federal regulations and guidance.
• Conduct education sessions and training, either formally or informally, for IRB customers based on new policy information or based on noted needs of the investigators utilizing IRB services.
• Provide education and training for UMCIRB members for discussion at UMCIRB meetings and UMCIRB member retreats.
• Provide guidance and interpretation to investigators that need assistance by educating and explaining why requests are being made.
• Provide study start up support for new investigators and their study team.
• Aid with preparation for external audits (FDA, sponsor audits, etc.) upon request.

• Serve as a primary contact for local investigators conducting human research in the screening and development of their proposals to ensure IRB regulatory requirements are addressed.
• Provide management, training, and support for UMCIRB members.
• Work with the Director and other UMCIRB staff to support functions of the IRB Committees.
• Develop education, training and resources for a wide variety of investigators and other customers based on hot topics, new federal guidance or local policies/rules.
• Conduct preliminary screening and evaluation of human research studies submitted for UMCIRB review to assess adherence to requirements for IRB approval.
• Provide effective feedback to investigators based on identified issues prior to review by the UMCIRB and provides mediation to identify and resolve issues.
• Employ critical thinking to solve moderately complex problems and effectively use available tools in problem solving and analysis.
• Accurately conveys UMCIRB determinations to investigators via the electronic IRB submission system.
• Identifies, plans and implements strategies to enhance the research submission and review process.
• Consistently operates according to UMCIRB policies and procedures for the protection of human participants in research.
• Provide human subject research guidance and education to UMCIRB staff and committee members, and faculty/staff/student investigators (individually or departmental).
• Interact and communicate with other local institutional and regulatory officials regarding human research.
• Assist Director by researching, proposing and developing necessary and appropriate policy/procedure changes within the UMCIRB according to local, state and federal policy changes and guidance.
• Consult with and query federal regulatory agents (OHRP, FDA, DOD, etc.) as needed for guidance to ensure UMCIRB's satisfaction of regulatory requirements.
• Draft and maintain Individual Investigator Agreements with individual research team members.
• Draft, review and execute IRB Authorization Agreements with collaborating institutions and external IRBs.

• Other Duties as assigned.

• Master's Degree, or Bachelor's degree and three years of experience in a related discipline.
• Experience with electronic data management systems.
• Experience with regulatory documents and interpretation of said documents and summarizing information to convey to relevant parties.
• Experience in the development of standard operating practices and educational workshops & training.
• Experience with post-IRB approval monitoring.
• Experience working in a university and/or research setting.

• Certification as an IRB Professional (CIP); Clinical Research Professional (CCRP); or Clinical Research Associate (CRA) or eligibility to apply for certification.
• Knowledge of biomedical research, social, behavioral or education research, data security and confidentiality, multi-site and collaborative research.
• Ability to work with people with broad backgrounds.
• General knowledge of Good Clinical Practice (GCP), ICH, FDA, OHRP, federal regulations related to human subjects' research as well as the ethical principles in the Belmont Report.
• Ability to work with diplomacy and tact while working with high level faculty members and staff.
• Strong verbal and written communication skills and good customer service skills.
• Ability to multi-task and prioritize work assignments.

In order to be considered for this position, applicants must complete a candidate profile online via the PeopleAdmin system and submit any requested documents. Additionally, applicants that possess the preferred education and experience must also possess the minimum education/experience, if applicable.