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Clinical Research Report Evaluator
hace 2 meses
When our values align, there's no limit to what we can achieve.
We are seeking dedicated professionals with extensive experience as Clinical Research Associates (CRAs) to work remotely as Senior CRAs or Report Reviewers.
Your role at Parexel
As a CRA, you will have the chance to exceed the expectations of a conventional clinical monitor. You will be responsible for leveraging your expertise to foster and maintain relationships with clinical sites, ensuring they are positioned for success. Acting as the primary point of contact for the sites, you will address and resolve any issues or inquiries that arise. Your responsibilities will include managing site quality and performance from the initial identification phase through to the study's conclusion.
At Parexel, you will benefit from state-of-the-art technology and tailored training that aligns with your individual experience. Expect reduced travel requirements and a lighter protocol load compared to industry standards. Your contributions may be recognized through a bonus incentive program, opportunities to engage in various therapeutic areas, and pathways 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 to conduct qualification visits (QVs), site initiation visits (SIVs), monitoring visits (MVs), and termination visits (TVs) at assigned clinical sites, generating comprehensive visit reports. Cultivate relationships by ensuring the integrity of the study and employing problem-solving skills to build rapport with site personnel. Safeguard patient welfare by reviewing trial performance at designated sites, ensuring the rights and well-being of human subjects are protected in accordance with the study protocol. Enhance productivity by developing patient recruitment strategies in collaboration with clinical sites to meet enrollment targets while ensuring compliance with approved standard operating procedures (SOPs), protocols, Good Clinical Practice (GCP), and relevant regulatory requirements. Ensure data quality by evaluating the integrity of reported data, site efficacy, and drug accountability. Execute monitoring tasks by overseeing the completeness and quality of regulatory documentation and performing site document verification.Qualifications
On your first day, we expect you to possess:
A minimum of 5 years of CRA experience. The ability 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 and the ability to operate with minimal oversight. A client-centric approach and a flexible attitude towards assignments and new learning opportunities. The capability 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. Proficiency in computer skills, including familiarity with Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and MS Office applications such as Excel and Word.