Senior Clinical Research Associate

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. PXL FSP has an exciting opportunity for a Senior CRA !

The Senior Clinical Research Associate is responsible for the following: Act as the primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Key Accountabilities: Site Management Responsibilities Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.

Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents. Gains an in-depth understanding of the study protocol and related procedures.

Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready. Participates & provides inputs on site selection and validation activities.

Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased. Subjects’ right, safety and well-being are protected.

Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.

Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close