Research Regulatory Manager, Remote

UofL Health•Work from Home - KY, KY

1d•Remote

About The Position

The Research Regulatory Manager position is responsible for developing the training and education for researchers as needed to meet the regulatory requirements to conduct clinical research studies in UL Health. Position will build and maintain relationships with physicians, nurses, IT, Marketing, Supply Chain and leadership as needed to promote and support research. Assists with development of goals, policies and procedures as needed for oversight of clinical research. Position is responsible for monitoring compliance with policies, procedures, and governing regulations, including the informed consent process and HIPAA authorizations. The position works closely with the researchers and the corporate compliance team to identify and mitigate risks through education and process development. Position responsible for oversight of IRB submissions, study review process and research personnel vetting.

Requirements

Bachelor’s degree (required)
Experience in clinical research, human subjects’ protection regulations, including HIPAA authorizations, and IRB process (required)
none (required)

Nice To Haves

5 years of experience in research administration (preferred)
Professional certification such as CCRP, CHRC, ACRP-CP (preferred)
none (preferred)

Responsibilities

Develop training and education related to research processes and procedures and present to stakeholders.
Audit and monitor the informed consent process for research conducted within UL Health.
Assist in preparation for study monitoring visits for CMG studies.
Review monitoring visit findings and provided training and education as needed.
Work with the Health Information Management team and researchers to ensure adequate documentation in medical record.
Train and supervise the Research Regulatory Coordinators, overseeing IRB process and research personnel vetting process.
Facilitate and lead planning meetings for new studies as needed and serve as liaison to internal stakeholders, such as marketing, IT, supply chain and patient care teams.
Oversee facility and systems access for study monitors.
Review all study submissions to ensure HIPAA compliance prior to facility approval.
Review completed consent forms for accuracy and congruence with contracts.
Review protocols, waivers, consent documents and data collection sheets to determine if any changes are needed for HIPAA authorization to be congruent with protocol.
Performs other duties as assigned