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Job Title:

Manager, SOAR Clinical Research Team Operations

Department:

Medicine | Psychiatry

The Manager, SOAR Clinical Research Team Operations is a key leadership position within the State of Ohio Adversity and Resilience (SOAR) initiative. SOAR is a state of the art, multigenerational study of family/ household units that focuses on a bio-psycho-socio-environmental (BioPSE) model of the risk for, expression of, and protection from persistent distress, suicide, and overdose. There is discovery of pathways to resilience within individuals, and extending to families, social groups, educational settings, workplaces and communities The study includes a brain-based study of health of families. This position will direct report to the Deputy Director, SOAR Operations and provide routine communications on status of clinical research team deliverables; provides direct oversight and day to day management of the clinical research assistants and clinical research coordinators to ensure the implementation and execution of the data collection and participant interaction components of SOAR across the State of Ohio. This position plans, implements & oversees daily conduct of all SOAR protocol activities including mobile site set up and management; ensures informed consent authorization is obtained & administered in compliance to regulatory & sponsor requirements; facilitates adherence to Manuals of Procedures for the collection, processing & evaluation of biological samples, as well as all data collection, scheduling, conduct and follow-through of research visits. The manager is responsible for the team’s training (including elements of partner site training), adherence to manuals of procedures and monitors all study activity to ensure compliance with Institutional Review Boards (IRB), DHHS, federal, state & sponsor regulations. This position participates in planning and preparing for external compliance, quality assurance & control reviews; participates in development of new research protocols and planning of goals to meet study requirements; assigns team member responsibilities; assists with preparation and submission of publications, research reports, and grant proposals; interviews, hires, manages performance & time sheets and conducts annual performance reviews. This position requires up to 20% in state travel to facilitate staff training, adherence to manuals of procedures and compliant study conduct.

MINIMUM REQUIRED QUALIFICATIONS

Bachelor's degree in biological sciences or an equivalent combination of education and experience required; 5 years of relevant experience required; extensive experience in a clinical research capacity conducting clinical research studies required; experience managing or supervising team members required; Clinical research certification from SoCRA (Society of Clinical Research Associates) or ACRP (Association of Clinical Research Professionals) required; extensive knowledge of clinical research regulations, guidelines & compliance issues required. A minimum of two years of experience working with patients/participants with mental illness and/or substance use disorders is preferred. Requires successful completion of a background check. Selected candidates may be required to complete a pre-employment physical, including a drug screen.

Additional Information:

Location:

Clinical Research and Innovation Facility (0200)

Position Type:

Term (Fixed Term)

Scheduled Hours:

40

Shift:

First Shift

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