Recruit studies
Serve as the central contact for sponsors
Receive all pharmaceutical and device protocols that utilize WellStar facilities and the WellStar Physicians Group.
Coordinate review of protocols by all affected departments for capabilities of departments/institution to support the protocol
Develop pricing for resource utilization required to perform the protocol
Review and negotiate contracts and study budgets
Coordinate scientific review of protocol by investigators/medical staff
Receive and track regulatory documentation
Serve as central contact for IRBs
Coordinate staff education as required by the protocol
Participate in site qualification, site initiation, and monitoring visits by sponsors
Oversee investigational device accountability and tracking
Oversee drug accountability
Responsible for coordinating and ensuring compliance with new investigator/coordinator orientation and training
Responsible for coordinating and ensuring compliance with continuing education requirements for investigators/coordinators
Oversee outsourced resource utilization
Maintain appropriate policies and procedures
Maintain compliance with regulatory agencies (federal, state, JCAHO, etc)
Assist with patient recruitment
Develop and coordinate a marketing program for research activities
Employ and coordinate study coordinators to assist with patient enrollment, monitoring visits, and required follow-up