Clinical Research Associate – CRA I/II

🕒 July 10

🎸 Tennessee – Remote

🎸 Tennessee – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 55%

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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, taking overall responsibility for allocated sites • Develop strong site relationships and ensure continuity through all phases of the trial • 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 an in-depth understanding of study protocols and related procedures • Coordinate and manage tasks with sponsor roles to achieve site readiness • Participate in and provide input on site selection and validation activities • Perform remote and on-site monitoring and oversight activities • Ensure site data are complete, accurate, and unbiased and protect subjects' rights, safety, and well-being • Conduct validation, initiation, monitoring, and closeout visits; prepare timely, clear, comprehensive, and accurate reports • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and closeout • 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 • Maintain information and documentation in CTMS, eTMF, and other required systems • Contribute to CRA team knowledge as a process subject matter expert, buddy/mentor, and best-practice sharer • Support or lead audits and inspection activities • Perform co-monitoring visits where appropriate • Complete required training, timesheets, expense reports, and CV updates; comply with Parexel/client processes, ICH-GCP, and applicable requirements

🎯 Requirements

• Oncology experience preferred • Fluent in local languages and English (verbal and written) • Good understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH and country clinical research law and guidelines • Good understanding of Global, Country/Regional Clinical Research 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, including MS Office and clinical IT applications on computer, tablet and mobile devices • Ability to adapt to new IT applications on various devices • Ability to understand and analyze data/metrics and act appropriately • Ability to manage complex issues in a solution-oriented manner • Root cause analysis and preventative/corrective action implementation • Effective time management, organizational, interpersonal, conflict management, problem-solving skills • Ability to work independently across multiple protocols, sites, and therapy areas • Ability to set priorities and handle multiple tasks simultaneously in a changing environment • Ability to work effectively in a matrix multicultural environment • Ability to establish culturally sensitive working relationships • Customer focus and quality/compliance mindset • 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 2 years of direct site monitoring experience in bio/pharma/CRO • Bachelor's degree preferred with a strong emphasis in science and/or biology