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East Carolina University · 1 day ago

Senior Research Analyst for the Institutional Review Board

Greenville, NC

Full-time

Onsite

Mid, Senior Level

$22K/yr - $22K/yr

3+ years exp

East Carolina University is seeking a Senior Research Analyst for the Institutional Review Board to support the administration of human research review and approval processes. The role involves providing guidance to investigators and ensuring compliance with institutional and regulatory requirements regarding human subjects in research.

Responsibilities

Assist manager with developing annual monitoring plan to include a schedule for monitoring targeted studies

Coordinate, schedule and perform routine post IRB-approval monitoring of 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

Qualification

IRB approval processRegulatory complianceHuman subject researchData management systemsClinical PracticeCustomer service skillsMulti-taskingCommunication skillsCritical thinking

Required

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

Preferred

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