Clinical Research Associate - CRA II/Senior

September 15

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+

💰 Venture Round on 1990-01

Description

• 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 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, ensure 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 also ensuring compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s). • 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. • Bachelors 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 with respect to assignments and new learning. • The ability to manage multiple tasks, evaluate a variety of unpredictable scenarios and achieve project timelines while being able to apply your understanding of study protocol(s). • An honest and ethical work approach to promote the development of life changing treatments for patients. • Strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS) and MS-Office products such as Excel and Word.