Senior Clinical Research Associate – Oncology

🕒 May 19

🐊 Florida – Remote

🐊 Florida – Remote

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs • Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely • Partner with Clinical Trial Liaison (CTL) and other client functions (e.g., Study Start-Up, Global Partnerships and Trial Optimization) to support site activation and deliverables • Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct • Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements • Prepare and maintain Oversight Monitoring Plan • Perform review of study metrics, assess CRO Clinical Research Associate (CRA) and Investigator Site performance and identify sites for oversight monitoring visits • Conduct Oversight Monitoring Visits at sites, either independently or alongside CRO CRA • Review site source documentation and verify accurate data capture (ALCOA principles) • Review and report on status of study conduct at the investigator site ensuring appropriate follow up of any identified issues/action items • Ensure site regulatory files are current and verify timely submission of study documentation, including safety reporting • Write and submit accurate monitoring visit reports, oversight monitoring visit reports, and study correspondence in a timely manner • Periodically verify completeness of site documentation (e.g., investigator site file/regulatory binder contents) • Identify and record protocol deviations, escalate non-compliance, and resolve study-related issues as necessary • Track, trend, and report issues, escalating them to the appropriate teams when required • Maintain ongoing communication with site personnel, study teams, CTLs, Central Monitors, and CRO CRAs • Actively participate in team meetings and process improvement initiatives to enhance study outcomes • Support inspection readiness activities and ensure sites maintain data integrity and protocol deliverables

🎯 Requirements

• Bachelor's degree (or equivalent) • Minimum of 5 years of related experience for Senior CRA • Strong analytical problem-solving skills and critical thinking abilities • Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA) • Effective communication and interpersonal skills to build relationships internally and externally • Familiarity with medical terminology and proficiency in IT applications, including Microsoft Office, EDC, CTMS, and data repositories • Demonstrated ability to deliver clear and concise written reports • Effective prioritization and time management skills

🏖️ Benefits

• Health insurance • Professional development opportunities