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Clinical Research Associate II
2 months ago
About the Role
We are seeking a highly skilled Clinical Research Associate II to join our team at PRA Health Sciences. As a Clinical Research Associate II, you will be responsible for conducting clinical trial site visits, including evaluation, initiation, monitoring, and close-out.
Key Responsibilities
- Conduct clinical trial site visits to ensure compliance with regulatory requirements and study protocols.
- Oversee and report on the conduct of clinical trials at a site level, including online site visit reports and updates to electronic management systems.
- Proactively manage site relationships, including building and maintaining professional relationships with site staff.
- Facilitate subject enrollment, incorporating recruitment strategies and action plans at site level.
- Maintain site audit/inspection readiness and ensure appropriate safety reporting.
- Verify electronic case report form data against written and electronic source documentation.
- Respond to site queries and escalate issues in accordance with processes and timelines.
- Conduct IP accountability and reconciliation, and facilitate implementation of new technologies and systems at clinical sites.
- Maintain site study supplies.
Requirements
- Bachelor's degree in a scientific discipline or nursing equivalent.
- At least 2 years of on-site monitoring experience in phase II and phase III trials.
- Working knowledge of Electronic Data Capture (EDC) systems.
- Experience in the oncology disease area is preferred.
- Comprehensive knowledge and understanding of ICH-GCP.
- Fluent oral and written English language skills.
- Able and willing to travel up to 60% of the time.
- Possession of a full driver's license.
- Able and willing to work from a designated home office.
- Competent computer skills, including working knowledge of common software packages.
- Working knowledge of trial management databases and online systems.
About PRA Health Sciences
PRA Health Sciences is a leading global contract research organization (CRO) that provides a comprehensive range of services to support the development of new medicines and treatments. Our mission is to improve human health by advancing the development and delivery of innovative therapies.
What We Offer
- A competitive salary and benefits package.
- A range of health insurance options to suit your needs.
- Competitive retirement planning offerings.
- A global Employee Assistance Programme (EAP) to support your well-being.
- Life assurance.
- Flexible country-specific optional benefits.
