Senior Clinical Research Associate - Oncology

The Senior Clinical Research Associate (Sr. CRA) plays a vital role in managing and monitoring investigator sites for clinical trials, ensuring that patient safety and quality standards are upheld in compliance with applicable laws and Good Clinical Practices (GCP). You will be accountable for building strong relationships with investigator sites to facilitate clinical trial delivery, enhance patient safety, and ensure compliance. Key Responsibilities: Oversee the execution of clinical trials in alignment with the Study Monitoring Plan (SMP) and applicable regulations to achieve project goals and maintain high quality. Manage all operational aspects of clinical trial activities at investigator sites from activation to database lock, ensuring timelines and quality requirements are met. Act as the primary contact for assigned investigator sites, collaborating closely with the Site Care Partner (SCP) to ensure optimal site performance. Facilitate communication among the study team, vendors, and investigator sites to streamline information flow and support trial progress. Conduct site development and provide training to site personnel to ensure compliance with protocols and safeguard patient welfare. Attend investigator meetings as necessary and support enrollment efforts by addressing site activation and recruitment challenges. Conduct on-site and remote monitoring to ensure adherence to established procedures and emerging best practices during all stages of the trial. Monitor and report on adverse events and serious adverse events in collaboration with the Drug Safety Unit. Document all necessary reports, updates, and metrics related to trial activity, ensuring compliance with timelines. Identify, address, and resolve any issues at investigator sites promptly, implementing preventive actions as needed. Ensure proper oversight of investigational products at sites through effective management of handling and storage conditions. Assist in data release activities as required, and undertake responsibilities of an unblinded monitor when appropriate. Required Skills: Deep understanding of clinical trial methodologies and regulations including ICH/GCP, FDA, and local country laws. Minimum of 3 years of experience in clinical research site monitoring, with at least 2 years in Oncology preferred. Experience in therapeutic areas such as Oncology, Vaccines, Internal Medicine, or Infectious Diseases is a plus. Fluency in English and the native language of the region you are working in. Willingness to travel 60-80% of the time, with a valid driver's license and passport. Educational Background: Bachelor's degree in life sciences or a professional degree in a relevant field such as nursing, pharmacy, or medicine. Parexel is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Created: 2026-03-04