Clinical Research Associate – Oncology

🔥 2 minutes ago

🏛️ District of Columbia, Florida, +6 more states – Remote

🏛️ District of Columbia – Remote 🐊 Florida – Remote 🏈 Ohio – Remote 🦀 Maryland – Remote 🔔 Pennsylvania – Remote 🎸 Tennessee – Remote 🤠 Texas – Remote ⚔️ Virginia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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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

• Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites. • Develops strong site relationships and ensures continuity of site relationships through all phases of the trial • Performs clinical study site management/monitoring activities in compliance with International Conference on Harmonization / Good Clinical Practices, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated Documents • Gains an in-depth understanding of the study protocol and related procedures • Coordinates and manages various tasks in collaboration with other sponsor roles to achieve Site Ready • Participates and provides inputs on site selection and validation activities • Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased; Subjects’ right, safety and well-being are protected • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, closeout visits and records clear, comprehensive, and accurate visit & non-visit contact reports appropriately in a timely manner • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance • Identifies, assesses, and resolves site performance, quality or compliance problems and escalates per defined CRA Escalation Pathway as appropriate in collaboration with Clinical Research Manager and Partner Line Manager • Manages and maintains information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines • Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required • Supports and/or leads audits/inspection activities as needed • Performs co-monitoring visits where appropriate

🎯 Requirements

• Minimum 2 years of direct on site monitoring experience in biotech/pharma/CRO organization • Oncology monitoring experience required • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines • Hands on knowledge of Good Documentation Practices • Proven skills in Site Management including management of site performance and patient recruitment • Demonstrated high level of monitoring skill with independent professional judgement • Good IT skills (Use of MS office, use of various clinical IT applications on computer, tablet and mobile devices) and ability to adapt to new IT applications on various devices • Ability to understand and analyze data/metrics and act appropriately • Demonstrated high level of monitoring skill with independent professional judgement • Able to work highly independently across multiple protocols, sites, and therapy areas • Demonstrates commitment to Customer focus

🏖️ Benefits

• Health insurance • Professional development opportunities