About the position
At Parexel, we believe that our work is more than just a job; it’s a commitment to the patients we serve. As a Clinical Research Associate (CRA), you will be part of a dedicated team that approaches clinical research with empathy and heart. Our clinical operating model is designed to enhance effectiveness, minimize handoffs, and boost satisfaction for employees, clients, and sites alike. This role goes beyond the traditional responsibilities of a clinical monitor, as you will be the primary point of contact for clinical sites, ensuring they are set up for success and addressing any issues that arise. In this position, you will manage site quality and delivery from the initial identification of sites through to the close-out phase. You will leverage your expertise to conduct various types of visits, including qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV). Your responsibilities will also include generating detailed visit reports and fostering strong relationships with site staff to ensure the integrity of the study. Your role will be crucial in protecting patients by reviewing trial performance at designated sites and ensuring compliance with protocols and regulatory requirements. You will develop patient recruitment strategies in collaboration with clinical sites to meet enrollment timelines while maintaining adherence to standard operating procedures (SOPs) and Good Clinical Practice (GCP). Additionally, you will evaluate the quality and integrity of reported data and ensure proper documentation throughout the study process. At Parexel, we pride ourselves on providing world-class technology and training tailored to your individual experience. With less travel and a lower protocol load compared to industry standards, you will have the opportunity to work across multiple therapeutic areas and advance your career in clinical research. If you are looking for a role that offers impact, flexibility, and career development, Parexel may be the perfect fit for you.
Responsibilities
- Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV), and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
- Oversee the integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
- Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are safeguarded and are in accordance with protocol.
- Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines while ensuring compliance with approved SOPs, protocol/amendment(s), GCP, and applicable regulatory requirements.
- Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability.
- Monitor completeness and quality of regulatory documentation and perform site document verification.
Requirements
- 18+ months Clinical Research Associate (CRA) monitoring experience in clinical research with 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.
- Ability to work in a self-driven capacity with a sense of urgency and limited need for oversight.
- A client-focused approach to work with a flexible attitude towards assignments and new learning.
- Ability to manage multiple tasks, evaluate a variety of unpredictable scenarios, and achieve project timelines while applying understanding of study protocols.
- An honest and ethical work approach to promote the development of life-changing treatments for patients.
- Strong computer skills, including knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word.
Benefits
- Bonus incentive program
- Opportunities for career advancement
- World-class technology and training
- Less travel and lower protocol load compared to industry peers
