When our values align, there's no limit to what we can achieve.
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. We take our work personally, we do it with empathy and we're committed to making a difference.
About Parexel
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®.
About the Role
We are seeking a number of Senior Clinical Research Associate I’s & II’s (Senior CRA I & II) to join our Functional Service Provider (FSP) team in a remote capacity. In this role, you will partner with a dedicated sponsor to support the successful delivery of oncology clinical trials, ensuring data integrity, patient safety, regulatory compliance, and operational excellence across assigned investigative sites.
As a study level clinical monitoring professional, you will manage assigned protocols and investigative sites throughout the clinical trial lifecycle, from site activation through study closeout. Working collaboratively with site personnel, study teams, and cross functional stakeholders, you will help drive enrollment goals, support protocol compliance, oversee data quality, and contribute to the efficient execution of studies that have the potential to improve patient outcomes.
This position offers the opportunity to work on complex oncology studies in a high visibility environment while developing strong site partnerships and influencing study delivery through both virtual and onsite monitoring activities. You will be part of a team committed to advancing clinical research excellence and accelerating the development of innovative therapies for patients worldwide.
Key Responsibilities
· Lead monitoring activities for assigned oncology clinical trial sites in accordance with the Clinical Monitoring Plan and applicable regulatory requirements.
· Support site initiation and activation activities, including training, collection of essential documentation, system access readiness, and preparation for first subject first visit.
· Drive site recruitment and enrollment support activities by maintaining regular communication with investigator sites and addressing recruitment challenges.
· Ensure compliance with protocol requirements, ICH GCP guidelines, local regulations, and sponsor processes throughout study conduct and closeout.
· Conduct onsite and remote monitoring visits, source document review, and source data verification to ensure clinical data accuracy, completeness, and quality.
· Identify, communicate, and help resolve protocol deviations, data queries, safety related concerns, and site performance issues, escalating significant risks when appropriate.
· Review investigational product accountability, storage, security, reconciliation, and dispensing activities in accordance with study requirements.
· Maintain site regulatory documentation and ensure site files, study records, delegation logs, and training documentation remain complete and…