Clinical Trials Coordinator

4 days ago


Boston, Massachusetts, United States ECOG-ACRIN MRF Full time
Job Summary

We are seeking a highly skilled and detail-oriented Protocol Associate to join our team at ECOG-ACRIN MRF. The successful candidate will assist with the coordination and development of clinical trials protocols from concept to activation, working closely with disease committees, investigators, and other senior-level colleagues.

Key Responsibilities
  • Oversee assigned disease committees in all aspects of protocol development, including concept development, protocol development, NCI and CIRB submissions and responses, quality control reviews, tracking development timelines, and initiating addenda when needed.
  • Assist with all aspects involved in coordinating protocols for review, editing, and formatting the protocol/amendment for scientific and editorial accuracy and consistency with oversight from Project Coordinator.
  • Coordinate the group-wide notification of any change in study status, including activation, suspension, and termination.
  • Assist as lead contact for disease chairs, investigators, and other senior-level colleagues.
  • Maintain computer databases related to protocol development and status changes.
  • Plan and manage monthly teleconferences for assigned disease sites.
  • Generate committee tracking documents for use on monthly teleconferences.
  • Prepare high-level notes containing action items from monthly teleconferences.
  • Maintain computer databases related to protocol statuses (clinicaltrials.gov records and internal tracking).
  • Participate in departmental meetings, protocol development meetings, disease-specific committee meetings, and other conference calls as required.
  • Interact with other cooperative groups, the NCI, member coordinators, and investigators.
  • Prepare concept/LOI packets to be submitted to the ECOG-ACRIN Executive Committee in a timely manner on a monthly basis.
  • Review concepts/LOIs prior to Executive Committee, Steering Committee, and NCI submission.
  • Set up various conference calls on an as-needed basis, such as study concept/LOI calls, disease-specific working group calls, and protocol review calls.
  • Contribute to the development of protocol procedures.
  • Perform database searches.
  • Perform other duties as assigned by Protocol Development management.
Requirements
  • Bachelor's degree in a life science discipline from an accredited college or university and/or relevant professional experience is required.
  • Healthcare-related background.
  • Prior clinical and/or data services experience.
  • Proficiency in database and word processing skills, and MS Office.
  • Strong customer service skills.
  • Knowledge/experience with electronic data submission a plus.


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