Job Location : Detroit,MI, USA
GENERAL SUMMARY:
Under supervision, coordinates low-moderate complexity clinical research projects in compliance with the Code of Federal Regulations.
* Provides technical support to Principal Investigators.
* Analyzes protocol specific requirements and implements measures to ensure physician, patient, and clinician compliance.
* Reviews medical record and compiles data into sponsor provided database in support of the primary endpoint of the clinical trial.
* Identifies and reports adverse events to medical monitor, FDA, and all other governing bodies.
* Coordinates all external audits and monitoring visits, and serves as liaison between institution and sponsor.
* Serves as departmental and system-wide resource.
EDUCATION/EXPERIENCE REQUIRED:
* Requires an Associate's degree or 60 college credit hours or equivalent combination of related education healthcare or research experience.
* Organizational, analytical, and problem-solving skills required.
* Demonstrated verbal and written skills at professional level required.
CERTIFICATIONS/LICENSURES REQUIRED:
* CCRP SOCRA or ACRP and IATA certification preferred.
Additional Information