Regulatory Affairs Specialist I

University of Arkansas•Little Rock, AR

13d

About The Position

This position will be directly responsible for ensuring regulatory compliance and administrative management for multiple clinical trials, working closely with investigators, industry sponsors, contract research organization representatives, and UAMS institutional oversight offices. Workload will consist of industry-sponsored, foundation/private non-profit-sponsored, and investigator-initiated clinical trials. Position must be able to organize complex projects, provide attention to detail, and communicate effectively. Will apply knowledge of local policies and federal regulations and guidelines in support of an assigned clinical trial portfolio and the objectives of TRI. Contributes information and ideas related to areas of responsibility as part of a cross functional team. Ensures effective and efficient workflow and adherence to quality standards for staff/program and self. Position maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research. The employee will work directly with pharmaceutical company sponsors, institutional investigators, and research staff.

Requirements

Bachelor's degree plus 1 year of experience in clinical research and/or FDA Regulatory Affairs OR High School Diploma, GED, or formal education equivalent plus five (5) years of general research or similar experience.
Obtain CRS certification within 2 years of hire