Senior Clinical Trial Coordinator

1 week ago


Reston, Virginia, United States Meet Full time

We are seeking dedicated professionals to join our team in transforming cancer treatment. Our company is passionate about discovering and developing innovative cancer therapies, and we value collaboration, inclusivity, and respect in our work environment.

Job Summary

The Senior Study Management Associate will report to the Head of Clinical Operations and be responsible for overseeing clinical trial execution. This role will involve maintaining quality conduct of trials and data collection, working closely with study sites and investigators.

Key Responsibilities

  • Manage all aspects of clinical trials to ensure timely completion, within budget, and in compliance with SOPs, FDA regulations, and ICH/GCP guidelines.
  • Support the management of key study parameters, including start-up activities, enrollment, site management, data collection, and data reviews.
  • Develop and review clinical trial materials, such as informed consent forms, case report forms, and study manuals.
  • Evaluate and manage clinical study sites and vendors, negotiating contracts and budgets as needed.
  • Provide input to project objectives and manage project deliverables.
  • Provide routine study updates to the cross-functional operations team.
  • Develop action plans to address issues with investigational sites and/or vendors.
  • Assist with the creation of study-specific tools and manuals to ensure data quality.
  • Train new team members on study processes.
  • Track and maintain study metrics/progress and update the team regularly.

Requirements

  • Bachelor's degree in a scientific discipline or health-related field.
  • Minimum of 2 years of experience as a CRA in a biopharmaceutical company or CRO.
  • Previous experience with oncology clinical trials is strongly preferred.
  • Experience working on early development trials is a strong plus.


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