Senior Clinical Research Associate – Oncology

🕒 July 9

🇺🇸 United States – 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

• Contributes to the selection of potential investigators. • Trains, supports and advises Investigators and site staff in study related matters. • Confirms that site staff have completed and documented the required trainings appropriately. • Actively participates in Local Study Team (LST) meetings. • Drives performance at the sites and ensures timely resolution to study-related issues. • Performs regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the study. • Ensures data query resolution in a timely manner. • Prepares for and collaborates with the activities associated with audits and regulatory inspections.

🎯 Requirements

• 5+ years of on site monitoring experience in a CRO or pharma organization • 1+ years of oncology monitoring experience • Bachelor degree in related discipline, preferably in life science, or equivalent qualification • Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP. • Good knowledge of relevant local regulations. • Good medical knowledge and ability to learn relevant client’s Therapeutic Areas. • Basic understanding of the drug development process. • Good understanding of Clinical Study Management including monitoring, study drug handling and data management. • Excellent attention to details. • Good written and verbal communication skills. • Good collaboration and interpersonal skills. • Good negotiation skills. • Ability to travel nationally/internationally as required. • Valid driving license

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Professional development