Clinical Research Associate (CRA) - Oncology - US Any Region

Overview

Parexel is seeking a Clinical Research Associate (CRA) with oncology monitoring experience to manage clinical sites from identification through closeout and serve as the primary point of contact for site teams.

What you'll do

• 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.

What you'll need

• At least 18 months of direct onsite monitoring experience as a Clinical Research Associate.
• Oncology clinical trial monitoring experience.
• 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.
• Strong interpersonal, written, verbal, organizational, and problem-solving skills.
• Strong site relationship management, problem-solving, and communication skills.
• The ability to work independently with urgency and limited oversight.
• 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.
• Comfort collaborating within a matrixed team and communicating clearly with internal and external stakeholders.

Details

• Location: United States - Remote.
• Travel: onsite monitoring visits to assigned clinical sites.