The Research Review Analyst (RRA) works as part of a multi disciplinary team, under the auspices of the University of Pittsburgh Institutional Review Board. The Research Review Analyst is responsible for maintaining a current working knowledge of federal and state regulations pertaining to the responsible conduct of human subject's research, along with ensuring compliance with University of Pittsburgh policies and procedures.
The Research Review Analyst will conduct a thorough review of full board studies and will complete all necessary documentation in the online submission database. When appropriate, the RRA may facilitate discussions at full board meetings or participate as a board member to ensure that risks to human subjects are minimized, while ensuring that research is conducted in compliance with federal and state regulations and University of Pittsburgh policies and procedures.
As part of a service-oriented, outreach program, the RRA will provide consultation and training to members of the research community at large via telephone or through face-to-face meetings.
This position is open to a flexible work arrangement which includes in-office and hybrid options.
Serves as a regulatory expert responsible for managing the protocol review process by ensuring compliance with federal regulations, state law, and University of Pittsburgh policies and procedures. Provides regulatory and ethical training and guidance for IRB members and the research community at large through consultation and education
Serves as a regulatory expert responsible for managing the protocol review process by ensuring compliance with federal regulations, state law, and University of Pittsburgh policies and procedures. Provides regulatory and ethical training and guidance for IRB members and the research community at large through consultation and education
Protocol Review:
The Research Review Analyst (RRA) will be responsible for reviewing research protocols submitted by the research community for IRB approval. This review will encompass full board protocol submissions to ensure compliance with federal and state regulations, ethical considerations, and University of Pittsburgh policies and procedures. The employee will complete all necessary documentation of protocol reviews including correspondence with the research community, documentation forms and comments to the study team.
The employee will be responsible for the completion of all necessary documentation of protocol reviews including, but not limited to, correspondence with research community members, documentation forms and/or meeting minutes. The RRA will closely collaborate with the IRB Vice Chairs or other expert consultants, as appropriate; conduct pre-reviews as necessary to ensure the efficient and effective processing of protocols.
The employee will conduct pre-reviews of submissions to ensure accuracy and compliance with regulatory standards.
Consultations:
The Research Review Analyst will be responsible for answering general questions and providing basic consultation regarding the submission process to investigators and research coordinators. This responsibility includes meeting with investigators and/or coordinators before a research protocol is submitted to the IRB to ensure compliance with federal regulations. The employee will consult with senior analysts regarding more complex questions and/or submissions.
Educational Programs:
The Research Review Analyst is responsible for participating in staff development programs to acquire the knowledge necessary to conduct qualitative protocol reviews. The RRA will be asked to provide departmental education to other staff through HRPO/IRB internal staff development programs on an annual basis.
Other:
The employee must demonstrate the ability to assume special assignments not otherwise described as determined by HRPO/IRB management.
Excellent written and verbal communication skills are essential for this position, as the RRA must personally and electronically communicate with members of the research community on a regular basis.