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Senior Clinical Research Associate - Oncology

PAREXEL - Hartford, CT

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Job Description

Are you passionate about advancing clinical trials in oncology? As a Senior Clinical Research Associate (Sr. CRA), you will play a vital role in managing, monitoring, and closing out clinical trial sites. Your primary focus will be on ensuring patient safety and the quality execution of studies in compliance with Good Clinical Practices (GCP) and applicable laws. Join us in making a difference in the lives of patients! Your Key Responsibilities: Oversee and ensure the proper conduct of clinical trials in line with the Study Monitoring Plan (SMP), regulations, and organization standards. Manage clinical trial activities at designated investigator sites from activation to database lock, while ensuring timelines and quality are met. Act as the main point of contact for assigned sites, collaborating with Site Care Partners to maintain quality delivery at the sites. Facilitate communication between the study team, vendors, and investigator sites to ensure successful trial execution. Provide guidance and training to site personnel, ensuring ongoing compliance with protocols and patient safety. Support recruitment initiatives by attending investigator meetings and addressing activation and recruitment challenges. Conduct remote and onsite monitoring as needed, ensuring adherence to protocols and guidelines. Monitor and follow up on adverse events (AEs) and serious adverse events (SAEs) to ensure timely resolution. Document all required reports and updates, ensuring timely submission of Trial Master File (TMF) documentation. Identify and resolve issues at investigator sites, developing corrective and preventative actions when necessary. Assist with database releases and prepare for site close-out activities. Ensure proper oversight of investigational products at sites, including their storage and handling. Qualifications: Minimum of 3 years of monitoring experience in clinical research (preferably 2 years in Oncology). A strong understanding of clinical trial methodologies and regulations (ICH/GCP, FDA). Fluency in English and the local language of the sites you will manage. A Bachelor's degree in life sciences or a professional background in nursing, pharmacy, or medicine. Must possess a valid driver's license and passport, and be willing to travel 60-80% of the time. Join our team and help us shape the future of oncology clinical trials! #LI-LO1 #LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.

Created: 2026-03-10

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