The Multidisciplinary Acute Care Research Organization (MACRO), of the Department of Critical Care Medicine is seeking a Lead Clinical Research Coordinator to provide direct oversight to a team of clinical research coordinators.

This supervisory position is responsible for overseeing the daily operations of MACRO's clinical research service line, directing the implementation and conduct of multiple clinical trials, and ensuring all research activities are coordinated in compliance with federal, state, and local regulations. This position performs all essential clinical research coordinator duties to include:

• Maintaining regulatory compliance
• Frequent communication with various research entities internal and external to the University
• Screening patients to determine eligibility
• Completing study enrollment activities
• Monitoring and reporting adverse events and unanticipated events
• Providing clinical follow up in inpatient and outpatient settings
• Coordinating protocol related research procedures, study visits, and follow up appointments
• Completing and overseeing data entry and data management
• Maintaining source documentation in an organized manner
• Training healthcare personnel on study protocols to ensure adherence at the direction of the PI

Previous experience coordinating clinical trials or working in a research environment is required. Prior experience as a healthcare provider will also be considered. Experience in training and mentoring staff is desirable.

Qualified candidates must possess excellent communication skills, the ability to work independently, and strong computer skills. This position requires flexibility to work a varied schedule across multiple facilities. Scheduled hours may include overnights, evenings, weekends, and holidays. The incumbent will also be required to perform on-call duties 7–10 days per month.

Supervises clinical research staff and performs human resource actions. Prepares professional research documents, applications, manuscripts, and research papers; assists with complex research papers; and oversees Institutional Review Board (IRB) applications. Coordinates multiple, simultaneous research studies and audits research studies. Negotiates contracts, maintains budgets and expenditures, and orders supplies.

Position requires the ability to make independent decisions regarding study operations. Must be able to work at a computer using multiple software programs and make frequent visits to various ICUs and other campus locations to facilitate enrollment in research studies. Must be able to communicate effectively and provide guidance to staff.

The incumbent must be able to stand for extended periods and walk for extended distances. No heavy lifting required.