Senior Oncology Clinical Research Coordinator - Remote

American Oncology Management Company

Fredericksburg (VA)

On-site

USD 29,000 - 48,000

Full time

8 days ago
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Job summary

American Oncology Management Company seeks a Clinical Research Coordinator II (non-RN) to oversee performance of studies under PI supervision, managing multiple oncology trials with adherence to GCP, ICH and FDA guidelines.

Responsibilities include protocol coordination, regulatory submissions, informed consent discussions, data entry in EMR/EDC/CTMS, and ensuring safety reporting, trial materials handling, and sponsor communications.

Qualifications

  • 2–5 years oncology research/related medical science experience.
  • Familiarity with GCP/ICH and FDA guidelines.
  • Ability to coordinate complex protocol procedures.
  • Strong regulatory and data integrity practices.

Responsibilities

  • Coordinate care for patients on clinical research protocols.
  • Manage IRB/IEC submissions and site credentials.
  • Oversee data collection and entry in EDC/CTMS.
  • Ensure safety reporting and adverse event follow-up.
  • Handle investigational product receipt, storage and reconciliation.

Skills

Protocol coordination
GCP & FDA guidelines
IRB/IEC documentation
Data integrity & EDC/CTMS
EMR familiarity

Education

High school education
Some college / Bachelor's preferred
Licensed Practical Nurse desirable

Tools

MS Office Suite
EMR systems
CTMS / EDC tools

Job description

American Oncology Management Company seeks a Clinical Research Coordinator II (non-RN) to oversee performance of studies under PI supervision, managing multiple oncology trials with adherence to GCP, ICH and FDA guidelines.

Responsibilities include protocol coordination, regulatory submissions, informed consent discussions, data entry in EMR/EDC/CTMS, and ensuring safety reporting, trial materials handling, and sponsor communications.

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