Senior Clinical Research Associate – FSP

🕒 June 9

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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

• Has local responsibility for the delivery of the studies at allocated sites • Works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) • Acts as the main contact with the study site • Responsible for monitoring the study conduct to ensure proper delivery of the study • Responsible for the preparation, initiation, monitoring, and closure of assigned sites in clinical studies • Ensures compliance with Client Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations • 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 training appropriately • Ensures the sites are inspection ready at all times • Participates in Local Study Team (LST) meetings • Updates CTMS and other systems with data from study sites as per required timelines • Prepares study drug for destruction, if applicable • Ensures data query resolution in a timely manner • Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required

🎯 Requirements

• Proficient in written and spoken English language required • Fluency in local language(s) required • 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 Therapeutic Areas • Basic understanding of the drug development process • Good understanding of Clinical Study Management including monitoring, study drug handling and data management • 3+ years of experience as an on-site Clinical Research Associate (CRA) for the Senior CRA position and 1+ years of experience for the Clinical Research Associate role • Bachelor's degree in related discipline, preferably in life science, or equivalent qualification

🏖️ Benefits

• Ability to travel nationally/internationally as Required