Lead Clinical Research Coordinator

Lead Clinical Research Coordinator serves as primary resource in the execution of assigned clinical research studies in accordance with approved protocols administered by the non-cancer Center for Clinical Research Management (CCRM) for the Department of Neurological Surgery; plans, implements amp; oversees daily conduct of protocol activities; serves as primary reviewer of patient records to assess amp; identify patients who meet criteria for participation in research studies; recruits, interviews amp; promotes study to eligible patients; educates patients and families of purpose, goals, amp; processes of clinical study; leads patient enrollment activities amp; ensures informed consent authorization is obtained amp; administered in compliance to regulatory amp; sponsor requirements; facilitates collection, processing amp; evaluation of biological samples, as well as scheduling and follow-through of patient care appointments, procedures, amp; other diagnostic testing; monitors patients for adverse reactions to study treatment or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, amp; provide appropriate level of care; documents unfavorable responses and notifies research sponsors amp; applicable regulatory agencies; participates in collecting, extracting, coding, amp; analyzing clinical research data; monitors amp; ensures compliance with Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state amp; industry sponsor regulations; participates in planning and preparing for external compliance, quality assurance amp; control reviews; participates in development of new research protocols and contributes to planning of goals to meet study requirements; works closely with principal investigators upon awarding of new protocols and recommends team assignments; assists with preparation and submission of publications, research reports, and grant proposals; trains, mentors, approves timesheets, assists with annual Buckeye Performance goals and performance, and supervises staff.

Education Required

Bachelors Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required.

Experience Required

3-5 years experience in a clinical research capacity conducting clinical research studies required. Computer skills required.

Required Certification

Clinical research certification from an accredited certifying agency required (ACRP or SOCRA). The certification must be maintained while in this role.

Preferred Education and Experience

5 years of relevant experience required. 6-8 years of relevant experience preferred. Experience in a progressively responsible management capacity in a medical research environment preferred. Experience with neurological disorders is preferred.

Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.

FUNCTION / SUBFUNCTION : Research and Scholarship / Clinical Research

CAREER BAND : Individual contributor- Specialized

CAREER LEVEL : S4