Senior Clinical Review Specialist
hace 2 semanas
When our values align, there's no limit to what we can achieve.
We are seeking dedicated professionals with substantial experience as Clinical Research Associates (CRAs) to work remotely as Senior CRAs or Clinical Report Evaluators.
Your role here
At Parexel, the CRA position provides an opportunity to transcend the typical clinical monitoring responsibilities. CRAs are responsible for leveraging their expertise to cultivate and sustain relationships with clinical sites, ensuring they are well-prepared for success. As the primary contact for clinical sites, this role involves addressing and resolving site-related inquiries and challenges. You will also oversee site quality and performance from the initial identification phase through to study closure.
As a CRA, Parexel will equip you with state-of-the-art technology and tailored training that aligns with your individual experience. You can expect reduced travel requirements and a lighter protocol load compared to industry standards. Your dedication may be recognized through a bonus incentive program, opportunities to engage in various therapeutic areas, and a pathway for career advancement in clinical research. If you value impact, flexibility, and professional growth, Parexel could be your ideal workplace.
Key Responsibilities
Utilize your expertise. Conduct qualification visits (QVs), site initiation visits (SIVs), monitoring visits (MVs), and termination visits (TVs) at assigned clinical sites, and generate comprehensive visit/contact reports. Foster relationships. Ensure the integrity of the study and apply problem-solving skills to build rapport with site personnel. Safeguard participants. Assess the trial's performance at designated sites, ensuring the rights and well-being of human subjects are protected and in compliance with the study protocol. Enhance productivity. Collaborate with clinical sites to develop patient recruitment strategies that meet enrollment timelines while ensuring adherence to approved standard operating procedures (SOPs), protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. Ensure quality. Assess the quality and integrity of reported data, site efficacy, and drug accountability. Execute effectively. Oversee the completeness and quality of regulatory documentation and perform site document verification.About You
On your first day, we anticipate you will possess:
A minimum of 5 years of CRA experience. The capability to independently perform all clinical monitoring activities. A Bachelor's degree or equivalent in biological sciences, pharmacy, or a related health discipline. Strong interpersonal, written, and verbal communication skills within a collaborative team environment. Experience working autonomously, demonstrating a sense of urgency with minimal oversight. A client-focused mindset and a flexible approach to assignments and new learning opportunities. The ability to manage multiple tasks, assess various unpredictable scenarios, and meet project timelines while applying your understanding of study protocols. An honest and ethical work ethic to support the development of transformative treatments for patients. Proficient computer skills, including familiarity with Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office applications such as Excel and Word.-
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