Job Description

Project Coordinator, Protocol Development  (Oncology)



Date Posted:


Employment Type:



Mohamed Barami

Recruiter Email:

Job ID:

JN -072022-15163

Job Description

Project Coordinator, Protocol Development  (Oncology)

The Project Coordinator is responsible for managing all aspects of the protocol development process for a specific disease site or subset of disease sites.

  • Responsible for the oversight and management for all protocol development functions across all disease sites – NCTN and NCORP
  • Supervises and monitors staff
  • Participates in training of new staff and assists in the development of relevant training programs and other presentations
  • Develops SOPs and study documentation as needed and distributes studies for review
  • Coordinates reviewer input and incorporates consensus changes into protocols
  • Works to support protocol development staff in their interactions with study chairs and co-chairs, statisticians, data associates, the NCI, and field reviewers throughout all phases of the protocol development process
  • Assist in the development and implementation of quality control procedures.
  • Conducts quality control reviews of protocols and related documents for scientific and editorial accuracy
  • Assists staff with troubleshooting problem studies, identifying issues and resolving problems in a timely way
  • Assumes a leadership role within the Protocol Development department
  • Manages and conducts the weekly Protocol Development POD meetings
  • Conducts final review of protocols prior to major review and NCI submission
  • Participates in the hiring and interviewing of potential new employees
  • Assumes responsibility for multiple special projects, as assigned by the Senior Director 

      • A minimum of three (3) years of experience working in a clinical research setting, and oncology experience a plus
      • A minimum of three (3) years management/supervisory experience
      • Strong computer skills with proficiency with MS Office and other related systems applications
      • Knowledge of Good Clinical Practices (GCP) and understanding of ICH/FDA guidance for Good Clinical Practice (GCP)
      • Experience or education in medical or scientific area an advantage, particularly oncology

  • Bachelor's degree from an accredited college or university and/or relevant professional experience is required

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