Clinical Research Associate II-Cancer Center Protocol Office

Massachusetts General Hospital - Boston, MA

Full-time - Entry Level

Boston, MA

1,001-5,000 employees

Hospitals

About the position

The Clinical Research Associate II position at the Massachusetts General Hospital Cancer Center Protocol Office involves coordinating and monitoring multiple oncology clinical trials. The role focuses on maintaining regulatory compliance, ensuring data quality, and overseeing the progress of trials across various sites. The CRA will work under general supervision, engaging in a high volume of regulatory document coordination and clinical data review, without direct patient contact.

Responsibilities

• Track the progress of the trial across all participating sites, including accrual and biospecimen collection.
• Correspond with participating sites to support trial activities, answering questions about eligibility and study procedures.
• Prepare and distribute informational updates, including meeting minutes and safety reports.
• Communicate essential trial information and documentation, including protocol amendments.
• Facilitate database reviews and query resolution.
• Present the Sponsor-Investigator study status reports related to trial progress and assigned tasks.
• Verify adequate documentation of consent and eligibility criteria.
• Conduct onsite and remote monitoring visits and complete corresponding monitoring reports.

Requirements

• Bachelor's degree in a relevant field.
• Experience in clinical research and regulatory compliance.
• Strong time management skills.

Nice-to-haves

• Experience with oncology clinical trials.
• Familiarity with institutional and federal regulations governing clinical research.

Benefits

• Health insurance coverage.
• Paid holidays and vacation time.
• Professional development opportunities.