Senior Clinical Research Associate

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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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

• Act as the primary site contact and site manager throughout all phases of a clinical research study • Take overall responsibility for allocated sites • Develop strong site relationships and ensure continuity throughout all trial phases • Perform clinical study site management and monitoring activities in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, protocol, site monitoring plan, and associated documents • Gain in-depth understanding of the study protocol and related procedures • Coordinate and manage tasks with sponsor roles to achieve Site Ready • Participate in site selection and validation activities • Perform remote and on-site monitoring and oversight activities • Conduct validation, initiation, monitoring, and close-out visits • Prepare timely, clear, comprehensive, and accurate visit and non-visit contact reports • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out • Communicate with investigators and site staff regarding protocol conduct, recruitment, retention, deviations, regulatory documentation, audits/inspections, and site performance • Identify, assess, resolve, and escalate site performance, quality, or compliance problems • Collaborate with internal functional teams, vendors, IRBs/IECs, and regulatory authorities • Maintain information and documentation in CTMS, eTMF, and other systems • Act as a process subject matter expert, share best practices, and provide training • Support or lead audit/inspection activities • Mentor or buddy junior CRAs and perform co-monitoring visits • Contribute to business initiatives and projects • Complete required training, timesheets, expense reports, and CV updates

🎯 Requirements

• Fluent in local languages and English (verbal and written) • Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH, and country clinical research law and guidelines • Hands-on knowledge of Good Documentation Practices • Excellent understanding of global, country/regional clinical research guidelines • Demonstrated ability to mentor/lead • Proven site management skills, including independent management of site performance and patient recruitment • Demonstrated high-level monitoring skill with independent professional judgment • Good IT skills, including MS Office and clinical IT applications on computer, tablet, and mobile devices • Ability to understand and analyze data/metrics • Experience conducting site motivational visits to boost site enrollment • Ability to manage complex issues and work in a solution-oriented manner • Ability to perform root cause analysis and implement preventive and corrective action • Ability to mentor junior CRAs and perform co-monitoring visits • Effective time management, organizational, interpersonal, conflict management, and problem-solving skills • Ability to work independently across multiple protocols, sites, and therapy areas • Ability to set priorities and handle multiple tasks in a changing environment • Ability to work effectively in a matrix multicultural environment • Commitment to customer focus and quality/compliance • Ability to travel domestically and internationally approximately 65%-75% of working time; expected travel approximately 2-3 days/week • Current driver's license required • Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO • Bachelor's degree preferred with a strong emphasis in science and/or biology