Job Title: Clinical Research Associate

Work Location: Middlesex County, Massachusetts

Summary:

The Clinical Research Associate is responsible for monitoring clinical studies to ensure quality execution in compliance with Good Clinical Practices (GCP), applicable laws, and established standards. This role involves managing clinical partner relationships, resolving protocol-related issues, and collaborating with the study team throughout the lifecycle of clinical studies.

Responsibilities:

• Oversee the conduct of clinical studies to ensure adherence to Standard Operating Procedures, GCP, and regulatory requirements, meeting project goals and timelines.
• Manage operational aspects of clinical study activities from initiation through database lock, ensuring timely and high-quality deliverables.
• Act as the primary contact for clinical partners during study conduct, facilitating effective communication and issue resolution.
• Coordinate with the study team, vendors, and investigator sites to support information flow and study progress.
• Participate in investigator meetings, provide enrollment support, and address recruitment challenges in collaboration with the study team.
• Conduct remote and electronic monitoring for routine and close-out activities, ensuring compliance with procedures and emerging technologies.
• Monitor and report adverse events, resolve data queries, and ensure proper documentation and tracking of study activities within required timeframes.
• Oversee investigational product management, including receipt, storage, accountability, and destruction, and support database release and close-out activities as needed.

Qualifications:

• Bachelor's degree or professional degree in life sciences, nursing, pharmacy, medical background, or equivalent.
• Minimum 3 years of relevant experience in clinical research site monitoring; at least 2 years in Oncology preferred.
• Extensive knowledge of clinical study methodologies, ICH/GCP, and FDA regulations.
• Fluency in English is required.
• Ability to travel 30-40% as needed.
• Valid driver's license required.

Published Category: Clinical Operations & Development