About The Position

Winship is seeking qualified candidates for the Clinical Research Coordinator III position. This role independently manages significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects. The position involves training and guiding less experienced staff, overseeing data management, and interfacing with research participants to resolve study protocol-related issues. The coordinator will also authorize purchases for supplies and equipment maintenance, develop strategies for participant recruitment and retention, and periodically audit operations to ensure regulatory compliance. Responsibilities include monitoring IRB submissions, responding to sponsor and monitor inquiries, reporting SAEs, resolving study queries, and providing leadership in policy and process improvements. The role may also assist in developing grant proposals and protocols, and with appropriate credentialing, may perform phlebotomy, specimen collection, or diagnostics. Some supervisory duties may also be performed.

Requirements

  • High School Diploma or GED and seven years of clinical research experience.
  • Two years of college in a scientific, health related or business administration program and five years of clinical research experience
  • Licensed as a Practical Nurse (LPN) and four years of clinical research experience
  • Bachelor's degree in a scientific, health related or business administration program and three years clinical research experience
  • Master's degree, MD or PhD in a scientific, health related or business administration program and one year of clinical research experience

Nice To Haves

  • Certified Research Administrator (CRA) or Clinical Research Coordinator (CRC) preferred.

Responsibilities

  • Independently manages significant and key aspects of a large clinical trial or all aspects of one or more small trials, or research projects.
  • Trains and provides guidance to less experienced staff.
  • Oversees data management for research projects.
  • Interfaces with research participants and resolves issues related to study protocols.
  • Authorizes purchases for supplies and equipment maintenance.
  • Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials.
  • Periodically audits operations including laboratory procedures to ensure compliance with applicable regulations; provides leadership in identifying and implementing corrective actions/processes.
  • Monitors IRB submissions and responds to requests and questions.
  • Interfaces with study sponsors, monitors and reports SAEs; resolves study queries.
  • Provides leadership in determining, recommending, and implementing improvements to policies/processes.
  • Assists in developing grant proposals and protocols.
  • With appropriate credentialing and training may perform phlebotomy, specimens collection or diagnostics.
  • May perform some supervisory duties.
  • Performs related approved responsibilities as required.
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