Clinical Data Research Associate

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere. We work with focus, agility, and shared purpose - moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®. We are seeking a Clinical Research Associate (CRA) with a minimum of one year monitoring experience to join our team. As a CRA, you will manage clinical sites from identification through closeout, serving as the primary point of contact for site teams and helping ensure study quality, patient safety, regulatory compliance, and accurate clinical data. You will conduct onsite monitoring activities, build and maintain productive site relationships, address site issues, and support enrollment and study delivery. Parexel provides world-class technology, training tailored to your experience, opportunities to work across therapeutic areas, and pathways for continued growth within clinical research. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites, and prepare timely visit and contact reports.

• Manage site quality and delivery from site identification through closeout.
• Serve as the primary point of contact for assigned clinical sites, addressing questions and resolving issues to support successful study execution.
• Oversee study integrity and build effective relationships with investigators and site staff.
• Review trial performance at designated sites and help safeguard the rights, safety, and well-being of study participants in accordance with the protocol.
• Develop patient recruitment strategies with clinical sites to support enrollment timelines.
• Ensure compliance with approved standard operating procedures, study protocols and amendments, Good Clinical Practice, and applicable regulatory requirements.
• Evaluate the quality and integrity of reported data, site performance, and investigational product accountability.
• Monitor the completeness and quality of regulatory documentation and perform site document verification.

Strong site relationship management, problem-solving, and communication skills.

• A client-focused, flexible approach to assignments and continuous learning.
• The ability to manage multiple priorities, evaluate changing scenarios, apply study protocols, and meet project timelines.
• An ethical, patient-focused approach and strong attention to quality and detail.
• At least 12 months of direct onsite monitoring experience as a Clinical Research Associate.

Bachelor's degree or equivalent in biological science, pharmacy, or another health-related discipline.

• Knowledge of Good Clinical Practice, applicable regulatory requirements, and clinical trial processes.
• Experience using a Clinical Trial Management System, an Electronic Document Management System, and Microsoft Office applications, including Excel and Word.

Oncology, Ophthalmology, CAR-T, and/or MASH clinical trial monitoring experience preferred. Health, Vision & Dental Insurance

• Tuition Reimbursement
• Vacation/Holiday/Sick Time
• Flexible Spending & Health Savings Accounts
• Some roles may be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans. Join us and be part of a team where your contributions help shape the future of clinical research. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.