IRB Coordinator III Position Available In Shelby, Tennessee

Overview Summary The IRB Coordinator III works under minimal or no supervision and acts as the lead staff for the IRB office. The IRB coordinator III does not only perform a broad range of administrative and support functions, involving data management but also ensures that the staff in the IRB office is preparing IRB documents with accuracy. The IRB coordinator III prepares, extracts, manipulates, analyzes, and reports data to internal and external constituencies. The coordinator III reviews all the IRB documents for discrepancies and ensures that the necessary corrections are made. The coordinator serves as liaison between department and other constituents. The coordinator ensures compliance with federal, state and local regulations and sponsor and departmental standard operating procedures. The coordinator is responsible for demonstrating professional demeanor and maintaining confidentiality in all interactions both with internal and external contacts. Other duties may be performed as assigned. Travel may be required. Responsibilities + Maintains and Ensures an organized and efficient office by keeping department files and records in an accessible, orderly and current condition to assure continuous work flow in the department. + Ensures department is maintaining compliance with research trial guidelines and sponsor trial requirements by keeping documentation up-to-date and notifying staff of any changes. + Assists with developing, revising, reporting and maintaining regulatory trial documents as directed by sponsor, government and institution guidelines. + Communicates effectively and acts as a liaison between all parties involved in assigned research trials. + Records, types and distributes minutes of departmental and committee meetings, as assigned. + Obtains and maintains regulatory document and data entry training, as assigned and required by research trial personnel. + Completes assigned goals.

Requirements, Experience, Education Experience Minimum Requirement:

Direct experience as IRB coordinator for at least 3 years. Documented experience of working with clinical research facility and academic medical center

Preferred:

Proficiency with IRB-Manager software portal

Education Minimum Requirement:

High School Graduate and minimum of 2 years in a Clinical research position or 5 years’ experience as an administrative assistant in a research or medical setting

Preferred:

Associate Degree Training Preferred:

CITI Training;

Clinical Research Coordinator Certification Special Skills Minimum Requirement:

Must be proficient in Microsoft Office Suite, Internet Explorer and general office equipment. Excellent Written, verbal and organizational skills. Ability to Function and achieve high productivity and efficiency. Ability to write legibly and record information accurately as necessary to perform job duties. Knowledge of FDA and ICH GCP guidelines regarding clinical research. Knowledge of medical terminology

Licensure Minimum Requirement:

Professional certification encouraged

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