Clinical Research Associate - FSP

Role Summary

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.

Parexel ’s Functional Service Provider (FSP) is looking for CRAs II, SR CRAs I and II to join our team in Argentina, Brazil or Mexico.

The Clinical Research Associate II will be responsible for data integrity, data quality and ensuring compliance with ICH GCP and local requirements at the site level. Monitoring will be conducted in line with the Study Monitoring Plan and will be performed virtually for the majority of activities to supplement on-site visit requirements. The Clinical Research Associate II will collaborate with the Site Manager to assure that the site is in compliance with the protocol and is inspection ready.

The Senior Clinical Research Associate I (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and client standards. The Sr. CRA is accountable for site management and monitoring, managing investigator site relationships to ensure effective delivery of clinical trials (e.g. enrollment, database release), to safeguard the quality of investigator sites (e.g. patient safety, site quality and compliance with GCP), to maintain investigator and site staff engagement and satisfaction, and to enhance the company’s image with its external stakeholders. The Sr. CRA is responsible for the resolution of all protocol-related issues for assigned investigator sites and will work closely with the Site Care Partner (SCP), and other members of the study team, as required, in activities associated with the set-up, running and close-out of sites in a clinical trial.

Requirements

• For the Clinical Research Associate a mininum of 1 year as a clinical monitor with demonstrated experience of monitoring (virtual & onsite).
• For the Senior Clinical Research Associate a mininum of 3 years as a clinical monitor with demonstrated experience of monitoring (virtual & onsite).
• For the Senior Clinical Research Associate ii a mininum of 5 years as a clinical monitor with demonstrated experience of monitoring (virtual & onsite).

Education

• Educated to degree level (biological science, pharmacy, or other health-related discipline preferred) or equivalent nursing qualification or other equivalent experience
• Proficiency in local language preferred. English is required