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Oncology Clinical Research Coordinator II
2 months ago
Position Overview:
As an integral part of the Massachusetts General Hospital team, the Oncology Clinical Research Coordinator II plays a vital role in the oversight and management of clinical trials within the Cancer Center Protocol Office. This position focuses on the central coordination and regulatory compliance of multi-center oncology studies.
Key Responsibilities:
The Coordinator will undertake the following responsibilities under the guidance of the Clinical Research Manager:
- Monitor the progress of clinical trials across various sites, ensuring adherence to protocols and regulatory standards.
- Engage with participating sites to facilitate trial activities, including:
- Preparation and dissemination of updates, such as meeting summaries and safety reports.
- Communication of critical trial information, including protocol modifications and routine status requests.
- Support database evaluations and address any data discrepancies.
- Verify documentation related to patient consent and eligibility to confirm compliance with inclusion/exclusion criteria.
- Conduct both onsite and remote monitoring visits, compiling comprehensive monitoring reports.
- Review regulatory binders and essential documents for accuracy and completeness.
- Manage the collection and organization of necessary regulatory documents from participating sites.
- Facilitate the review of safety reports and adverse events with the Sponsor-Investigator.
- Submit required reports to regulatory bodies and stakeholders as necessary.
Qualifications:
The ideal candidate will possess:
- A meticulous attention to detail and strong organizational skills.
- Excellent problem-solving abilities and effective communication skills.
- The capability to work independently while managing multiple tasks.
- A willingness to travel for monitoring visits as required.
Experience:
A minimum of 1-2 years of relevant experience in clinical research is preferred.
Work Environment:
This role primarily operates in a remote setting, with occasional in-office presence required. Candidates should be prepared for limited domestic travel.
Join us in advancing cancer research and improving patient outcomes through dedicated clinical trial management.
