Clinical Research Associate

About the Role

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.

Key Responsibilities

• 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.

Candidate Profile

• 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.

Required Qualifications

• 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.
• Strong interpersonal, written, verbal, organizational, and problem-solving skills.
• Oncology, Ophthalmology, CAR-T, and/or MASH clinical trial monitoring experience preferred.