REPORTING RELATIONSHIPS/SUPERVISORY RESPONSIBILITIES

This IRB and Research Specialist reports to the IRB Director and has no direct reports. The IRB Department reports to the AVP of Research and the Institutional Official/Chief Integration Officer, Academic Affiliations.

POSITION SUMMARY

Under the supervision of the IRB Director, assists in coordinating all IRB activities including agenda and minutes preparation, preparing reports, advising investigators and research teams and implements continuing education for IRB members and researchers. Ensures compliance with federal guidelines and institutional policies and procedures governing research. Additionally, this individual will assist the Research Department in completing research projects and perform other duties as directed.

ACCOUNTABILITIES

All duties listed below are essential unless noted otherwise

Coordinates the functions of the IRB committee including: 1) develops meeting agenda and minutes; 2) makes meeting material available to IRB members; 3) ensure meeting quorum; 4) detailed communication with researchers/study personnel; and training and orientation tasks of new committee members. Performs preliminary administrative review of research protocols; identifies and consults with Director of problems and issues as needed. Performs post-approval monitoring of currently active studies. Communicates outcomes with researchers and IRB members. Tracks pending applications and advises researchers on the status of their submissions. Assists researchers in complying with conditions imposed by the IRB committee. Coordinates the review and the approval of expedited, exempt and non-human subject research submissions and IRB emergency requests. Maintains accurate serious adverse event (SAE) and safety report files. Coordinates educational programs for IRB members, researchers, and study personnel. Accessible for meetings before and after work, as necessary. Assists with research and departmental projects as directed.

REQUIRED QUALIFICATIONS

Education: Bachelor’s degree in public health, social science, medical ethics, or a related discipline.

Skills: Excellent written documentation skills with strong attention to detail, effective communication (verbal and interpersonal), organized, decisive, problem-solving ability, computer literate and database management. Must be able to interpret and apply complex ethical principles and regulations governing human subject research. Highly trustworthy and judicious regarding confidential human subjects’ research.

Years of Experience: 1-3 years related regulatory experience and knowledge of research.

License: N/A

Certification: N/A

PREFERRED QUALIFICATIONS

Education: Master’s degree in public health, social science, medical ethics, or a related discipline.

Skills: Familiar with public health and/or social science design, methods, and procedures as it relates to federal regulations.

Years of Experience: 3-5 years related regulatory experience and knowledge of research.

License: N/A

Certification: Certified IRB Manager (CIM) or Certified IRB Professional (CIP)

WORKING CONDITIONS

Personal Protective Equipment: As required by the facility.

Physical Demands: Must be able to move about hospital and between workstations.

The above list of accountabilities is intended to describe the general nature and level of work performed by the incumbent; it should not be considered exhaustive.

ProMedica is a mission-based, not-for-profit integrated healthcare organizational headquartered in Toledo, Ohio. For more information, please visit www.promedica.org/about-promedica

Qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, religion, sex/gender (including pregnancy), sexual orientation, gender identity or gender expression, age, physical or mental disability, military or protected veteran status, citizenship, familial or marital status, genetics, or any other legally protected category. In compliance with the Americans with Disabilities Act Amendment Act (ADAAA), if you have a disability and would like to request an accommodation in order to apply for a job with ProMedica, please contact employment@promedica.org

Equal Opportunity Employer/Drug-Free Workplace

Requisition ID: 86537