Location: METROHEALTH MEDICAL CENTER

Biweekly Hours: 80.00

Shift: 8-4:30

The MetroHealth System is redefining health care by going beyond medical treatment to improve the foundations of community health and well-being: affordable housing, a cleaner environment, economic opportunity and access to fresh food, convenient transportation, legal help and other services. The system strives to become as good at preventing disease as it is at treating it. Founded in 1837, Cuyahoga County’s safety-net health system operates four hospitals, four emergency departments and more than 20 health centers.

Summary: 

Provides oversight of other regulatory staff in mentoring and training in addition to preparing and managing the regulatory requirements of the clinical research studies. Assists the Principal Investigator with all regulatory responsibilities involved with opening and maintaining the protocol to closure. Coordinates aspects of protocol submissions, prepares and submits regulatory documents and maintains records on assigned studies to ensure regulatory compliance with MetroHealth policies as well as federal regulation and ICH/GCP guidelines. Acts as a liaison between the research team, sponsor and institutional departments or regulatory bodies. Plans and coordinates strategies for improving efficiency, action plans to improve quality and training regulatory personnel. Upholds the mission, vision, values, and customer service standards of The MetroHealth System.

Qualifications:

Required: Bachelor’s Degree in life science or other health related discipline or any equivalent combination of education, training, and experience in addition to the experience stated below. 5 years of clinical research support experience. SOCRA/ACRP/RAPS (or equivalent) certification or obtains one within a year of employment. Working knowledge of Good Clinical Practice guidelines and Code of Federal regulations. Excellent interpersonal, written, and oral communication skills. Demonstrate strong organizational skills. Solid experience in using MC Office programs and software including Word, Excel, PowerPoint, and Outlook. Ability to multitask, prioritize and manage multiple projects accurately and efficiently. Ability to interact effectively with a wide range of cultural, ethnic, racial, and socioeconomic backgrounds. Preferred: Master’s degree. Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Physical Demands: May need to move around intermittently during the day, including sitting, standing, stooping, bending, and ambulating. May need to remain still for extended periods, including sitting and standing. Ability to communicate in face-to-face, via phone, email, and other communications. Ability to read job-related documents. Ability to use a computer.