AddressGENERAL SUMMARY:
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.
Additional Information
