Clinical Research Associate I – FSP, Oncology Experience

🔥 16 minutes ago

🇧🇷 Brazil – Remote

⏳ Contract/Temporary

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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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 activities where required • Train, support and advise investigators and site staff on study-related matters, including RbQM principles • Confirm and document required site staff training, including ICH-GCP training • Participate in Local Study Team and National Investigators meetings as applicable • Initiate, monitor and close study sites in compliance with client procedures • Share patient recruitment and site progress information within the Local Study Team • Drive site performance and identify, resolve and escalate study-related issues • Update CTMS and other systems with study-site data • Manage study supplies, drug supplies and drug accountability • Perform remote and onsite monitoring visits and remote data checks • Perform SDR, CRF review and SDV according to the Monitoring Plan • Perform Site Quality Risk Assessments and adapt monitoring intensity • Ensure timely data query resolution and work with data management on study-data quality • Ensure accurate and timely Serious Adverse Event reporting and follow-up • Prepare and finalize monitoring visit reports in CTMS and provide feedback to Principal Investigators • Follow up on outstanding site actions • Escalate systematic or serious quality, privacy and compliance issues • Assist sites in maintaining inspection-ready ISFs • Prepare for and collaborate on audits and regulatory inspections • Collect and upload essential documents to the eTMF and support QC checks • Ensure study documents are ready for final archiving and completion of the local eTMF • Provide relevant research, site, investigator and competing-study information for the local market • Ensure compliance with ethics, company policies, legislation and applicable regulations • Collaborate with local MSLs as directed

🎯 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 • Previous oncology experience is required • Ability to understand and use computer systems/software in an enabled environment

🏖️ Benefits

• Fixed-term 9–12 months assignment • Remote work arrangement • Ability to work with remote collaborators • Opportunity to contribute to therapies that benefit patients • Global and local study team collaboration