Primary Location:

Work from Home - KY

Address:

P.O. Box 909 Louisville, KY 40201-0909

Shift:

Job Description Summary:

UofL Health is a not-for-profit 501(c)(3) fully integrated regional academic health system with nine hospitals, four medical centers, Brown Cancer Center, Eye Institute, more than 250 physician practice locations, and more than 1,200 providers in Louisville and the surrounding counties, including southern Indiana.
With more than 14,000 team members – physicians, surgeons, nurses, pharmacists and other highly-skilled health care professionals, UofL Health is focused on one mission: to transform the health of communities we serve through compassionate, innovative, patient-centered care.

Job Description:

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.

Essential Functions:

• 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.

Exempt position works 80 productive hours each pay period and paid biweekly.

Daily hours are flexible as long as no less than 80 productive hours are worked.

On occasion, position may require additional hours to meet deadlines or for special projects.

Other Functions:

• 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

Additional Job Description:

Education:

• Bachelor’s degree (required)

Experience:

• Experience in clinical research, human subjects’ protection regulations, including HIPAA authorizations, and IRB process (required)
• 5 years of experience in research administration (preferred)

Licensure:

• none (required)
• none (preferred)

Certification:

• Professional certification such as CCRP, CHRC, ACRP-CP (preferred)