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Clinical Monitoring Analyst

hace 2 meses


Medellín, Antioquia, Colombia Parexel A tiempo completo

At Parexel, we believe in the power of aligned values to drive success.

We are seeking dedicated professionals with extensive experience as Clinical Research Associates (CRAs) to join our team as Senior CRAs or Clinical Report Evaluators, working remotely.

Your Role

As a CRA at Parexel, you will have the chance to transcend the traditional clinical monitoring role. You will be responsible for leveraging your expertise to foster and maintain relationships with clinical sites, ensuring they are well-equipped for success. This includes being the primary contact for the sites, addressing their inquiries, and resolving any issues that may arise. You will oversee site quality and performance from the initial identification phase through to study close-out.

At Parexel, we provide you with state-of-the-art technology and tailored training that aligns with your individual experience. Expect reduced travel and a manageable 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 the ideal place for you.

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, while 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 participants 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 goals, while ensuring adherence to approved standard operating procedures (SOPs), protocols, Good Clinical Practice (GCP), and applicable regulatory requirements. Ensure quality by assessing the integrity and quality of reported data, site efficacy, and drug accountability. Execute monitoring of regulatory documentation completeness and perform thorough site document verification.

Candidate Profile

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 and minimal oversight. A client-centric approach and a flexible attitude towards assignments and new learning opportunities. The ability to manage multiple tasks, assess various unpredictable scenarios, and meet project timelines while applying knowledge of study protocols. An ethical and honest work ethic aimed at fostering the development of transformative treatments for patients. Proficient computer skills, including familiarity with Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and Microsoft Office applications such as Excel and Word.