The position requires using advanced knowledge of research regulations, guidance, and practice standards and applying this knowledge across a diverse portfolio of research. The position will provide a systematic, internal process that will increase compliance with federal, state, and institutional requirements and ensure that research staff follow the approved protocol and apply the ethical principles outlined in the Belmont Report.
Responsibilities include quality assurance monitoring of human research and IRB activities to confirm the conduct and oversight of research comply with regulations and follow professional best-practice standards. This proactive approach will minimize risks to human subjects and minimize regulatory risks at the investigator and organizational levels.
Monitor research and IRB activities for compliance with applicable federal regulations and guidelines, IRB requirements, and Baptist HRPP Policies and Procedures by:
performing periodic compliance reviews of human research studies and IRB activities under the HRPP QA/QI Plan;
providing investigators with QI recommendations and targeted training to ensure compliance;
providing the IRB with QI recommendations and targeted training to ensure that review and oversight activities align with regulations, guidance, and practice standards;
assisting investigators and the IRB with the development of Corrective and Preventative Action (CAPA) Plans as warranted;
preparing written reports that detail observations, regulatory risks, recommendations, and any other actions necessary to bring the research or IRB activity into compliance; and
reporting potential serious or continuing non-compliance with applicable regulations or institutional policies to the appropriate Baptist leadership
Review EMR/medical records of research participants, judge the impact of any non-compliance on study plans/processes, and communicate findings to investigators, and report monitoring plans and QA findings to various committees regularly.
Education: Bachelor’s Degree required or equivalent; Master’s Degree preferred
Experience: Minimum 5 years experience in Research, IRB or HRPP. Experience as a monitor or auditor for industry trials preferred.
Certification/Registration: CCRA, CCRC, ACRP-CP, CCRP, or SOCRA/ACRP
Internal Number: 2021-114729
About Baptist Memorial Healthcare Corporation
In keeping with the three-fold ministry of Christ — Healing, Preaching and Teaching — Baptist Memorial Health Care is committed to providing quality health care.
To create an expert system of care in the Mid-South where love abounds so that God can do the impossible.
Compassionate care and service
Teamwork and trust
Innovation and excellence
Respect for the individual and the value of diversity