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

• Local responsibility for the delivery of the studies at allocated sites • Active participant in the local study team(s) • Close collaboration with other CRAs and the Local Study Team/Local Study Associate Director (LSAD) • Monitoring study conduct to ensure proper delivery of the study • Responsible for preparation, initiation, monitoring, and closure of assigned sites in clinical studies • Contributes to the selection of potential investigators • Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study • Trains, supports, and advises Investigators and site staff in study related matters • Updates CTMS and other systems with data from study sites as per required timelines • Manages study supplies (Investigator Site File, drug supplies, etc.) • Performs monitoring visits (remote and onsite) • Works with data management to ensure robust quality of the collected study data • Ensures accurate and timely reporting of Serious Adverse Events and their follow ups • Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Client SOPs and local requirements

🎯 Requirements

• 3+ years of experience as an on-site Clinical Research Associate (CRA) for the Senior CRA position • 1+ years of experience for the Clinical Research Associate role • 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 • Bachelor's degree in related discipline, preferably in life science, or equivalent qualification

🏖️ Benefits

• Health insurance • Professional development