Clinical Research Associate II
hace 6 días
Parexel is seeking a highly skilled Clinical Research Associate II to join our Clinical Operations Team in Spain. As a key member of our team, you will be responsible for conducting site initiation visits, monitoring visits, and termination visits at assigned clinical sites, ensuring the integrity of the study and promoting rapport with site staff.
Key Responsibilities- Conduct qualification visits, site initiation visits, monitoring visits, and termination visits at assigned clinical sites, generating visit/contact reports.
- Build relationships with site staff, ensuring the integrity of the study and promoting rapport.
- Protect patients' rights and well-being, reviewing the performance of the trial at designated sites and ensuring compliance with protocol, GCP, and regulatory requirements.
- Drive productivity by developing patient recruitment strategies in conjunction with the clinical site, ensuring compliance with SOPs, protocol amendments, and regulatory requirements.
- Ensure quality by evaluating the quality and integrity of reported data, site efficacy, and drug accountability.
- Execute monitoring activities, including site document verification and regulatory documentation.
- Site management or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology.
- Ability to perform all clinical monitoring activities independently.
- Bachelor's or equivalent degree in biological science, pharmacy, or other health-related discipline.
- Strong interpersonal, written, and verbal communication skills within a matrixed team.
- Fluent knowledge of Spanish and English languages.
- Experience working in a self-driven capacity, with a sense of urgency and limited oversight.
- Client-focused approach to work and flexible attitude with respect to assignments/new learning.
- Ability to manage multiple tasks, evaluate unpredictable scenarios, and achieve project timelines.
- Honest and ethical work approach to promote the development of life-changing treatments for patients.
- Strong computer skills, including knowledge of CTMS, EDMS, and MS-Office products.
Parexel is a leading biopharmaceutical services company that provides a suite of services to help clients transform scientific discoveries into new treatments. We believe in our values of Patients First, Quality, Respect, Empowerment, and Accountability, and we are committed to making a positive impact on the world's health.
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