Senior Clinical Research Associate

🕒 2 days ago

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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 • Responsible for study start-up and regulatory maintenance when required • Trains, supports and advises Investigators and site staff in study related matters • Confirms that site staff complete required trainings, including ICH-GCP training • Actively participates in Local Study Team (LST) meetings • Initiates, monitors and closes study sites in compliance with client’s Procedural Documents • Drives performance at the sites and resolves study-related issues • Updates CTMS and other systems with data from study sites • Manages study supplies and drug accountability at study sites • Performs monitoring visits, remote data checks, and Source Data Review, CRF review, and Source Data Verification • Ensures data query resolution in a timely manner • Works with data management to ensure quality of collected study data • Ensures accurate and timely reporting of Serious Adverse Events and their follow ups • Prepares monitoring visit reports in CTMS and provides feedback to Principal Investigator • Follows up on outstanding actions with study sites

🎯 Requirements

• 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.

🏖️ Benefits

• Health insurance • Professional development opportunities