Clinical Research Associate engaging with clinical sites and managing trial quality for Parexel's biopharmaceutical services. Ensuring patient safety and compliance with regulatory protocols across designated clinical trials.
Responsibilities
Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites
Generate visit/contact reports
Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff
Review performance of the trial at designated sites and ensure rights and well-being of human subjects are safeguarded, in accordance with protocol
Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines, ensuring compliance with SOPs, protocol/amendment(s), GCP, and applicable regulatory requirements
Evaluate quality and integrity of reported data, site efficacy, and drug accountability
Monitor completeness and quality of regulatory documentation and perform site document verification
Requirements
Experience in clinical research (e.g. as a Clinical Research Coordinator)
Understanding of clinical trials methodology and terminology
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 the Spanish and English languages
Experience working in a self-driven capacity with a sense of urgency and limited oversight
A client-focused approach to work and flexible attitude toward assignments/new learning
Ability to manage multiple tasks, evaluate various unpredictable scenarios, and achieve project timelines
Honest and ethical work approach to promote development of life-changing treatments for patients
Strong computer skills including knowledge of CTMS, EDMS, and MS-Office products such as Excel and Word
Benefits
World class technology and training
Bonus incentive program
Opportunity to work within multiple therapeutic areas
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