Senior Clinical Research Associate – FSP

🔥 1 minute ago

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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

• Contribute to the selection of potential investigators • Support study start-up and regulatory maintenance, including site qualification visits and regulatory/EC/IRB submissions where required • Train, support, and advise investigators and site staff on study-related matters, including Risk Based Quality Management principles • Confirm required site staff training, including ICH-GCP training, and ensure inspection readiness • Participate in Local Study Team meetings and National Investigators meetings as applicable • Initiate, monitor, and close study sites in compliance with client procedures • Drive site performance, identify and resolve study-related issues, and escalate as appropriate • Update CTMS and other systems with study-site data within required timelines • Manage study supplies, drug supplies, and drug accountability; prepare study drug for destruction where applicable • Perform remote and onsite monitoring visits and remote data checks according to the study Monitoring Plan • Perform Source Data Review, Case Report Form review, and Source Data Verification • Conduct Site Quality Risk Assessments and adapt monitoring intensity • Ensure timely data query resolution and collaborate with data management on study-data quality • Ensure accurate and timely reporting of Serious Adverse Events and follow-ups • Prepare and finalize monitoring visit reports in CTMS and provide timely feedback to Principal Investigators • Follow up on outstanding site actions • Escalate systematic or serious quality issues, privacy breaches, protocol issues, and ICH-GCP compliance issues • Assist sites in maintaining inspection-ready Investigator Site Files • Prepare for and collaborate on audits and regulatory inspections • Ensure timely collection and uploading of essential documents into the eTMF and support quality-control checks • Ensure study documents are ready for final archiving and local eTMF completion • Provide research-related information on sites, investigators, and competing studies for the local market • Collaborate with local Medical Scientific Liaisons as directed

🎯 Requirements

• Excellent attention to detail • Good written and verbal communication skills • Good collaboration and interpersonal skills • Good negotiation skills • Proficient in written and spoken English language required • Excellent knowledge of international ICH-GCP guidelines • 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 a related discipline, preferably in life science, or equivalent adapted to local country market needs • Ability to travel nationally/internationally as required • Valid driving license per country requirements, as applicable

🏖️ Benefits

• Remote work arrangement • Full-time employment

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