Under minimal supervision, coordinates clinical research projects in compliance with the Code of Federal Regulations.
Provide technical support to Principal Investigators.
Analyze protocol specific requirements and implement quality assurance measures to ensure physician, patient and clinician compliance.
Abstract medical information from various sources in the patient medical record.
Report adverse events to medical monitor, FDA, and all other governing bodies.
Coordinate all external audits and monitoring visits, and serve as liaison between institution and sponsor.
Serve as departmental and system-wide resource.
EDUCATION/EXPERIENCE REQUIRED :
Bachelor\'s degree in Clinical Research, Biology, Chemistry, Nursing or other closely related field.
Two (2) years of relevant experience preferred.
Previous coordinator experience preferred.
Organizational and analytical and problem solving skills.
Demonstrated verbal and written skills at professional level.
CERTIFICATIONS/LICENSURES REQUIRED: SOCRA or ACRP and IATA certification preferred.
