Clinical Trial Coordinator: Research Ops & Compliance

Brigham and Women's Hospital, Inc.

Boston (MA)

On-site

USD 34,000 - 54,000

Full time

4 days ago
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Job summary

The Brigham and Women's Hospital, Inc. is seeking a Clinical Trial Coordinator to ensure trials are conducted per protocol, GCP, and sponsor standards.

You will work independently to support one or more trials, handling day-to-day project activities and coordinating with sites and monitors. Responsibilities include obtaining regulatory documents, reviewing site regulatory packages, maintaining study files, and preparing meeting materials.

Qualifications

  • 1-2 years of research-related experience required.
  • Familiarity with EDC and CTMS systems 2-3 years preferred.
  • Excellent organizational and communication skills are essential.

Responsibilities

  • Identify and initiate communications with sites to obtain regulatory documents.
  • Collect and review essential regulatory documents for completeness prior to submission.
  • Advise sites on protocol conduct and issue resolution.
  • Update internal databases, tracking systems, project plans, and study files.
  • Prepare materials for internal and external meetings; draft agendas and minutes.
  • Support trial processes and distribution of information to monitors.
  • Facilitate policy/process improvements for the department/trial.
  • Comply with SOPs.

Skills

Organizational skills
Communication skills
Autonomy
Project coordination

Education

Bachelor's degree in related field

Tools

EDC
CTMS

Job description

The Brigham and Women's Hospital, Inc. is seeking a Clinical Trial Coordinator to ensure trials are conducted per protocol, GCP, and sponsor standards.

You will work independently to support one or more trials, handling day-to-day project activities and coordinating with sites and monitors. Responsibilities include obtaining regulatory documents, reviewing site regulatory packages, maintaining study files, and preparing meeting materials.

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