Clinical Research Associate

Description

• Leverage your expertise. Conduct qualification visits (QV), site initiation visits (SIV), monitoring visits (MV) and termination visits (TV) at assigned clinical sites and generate visit/contact reports.
• Build relationships. Oversee integrity of the study and utilize problem-solving skills to promote rapport with the site and staff.
• Protect patients. 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.
• Drive productivity. 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).
• Ensure quality. Evaluate the quality and integrity of the reported data, site efficacy and drug accountability.
• Execute. Monitor completeness and quality of Regulatory Documentation and perform site document verification.

Qualifications

Highest qualification: University

• 18+ months of direct onsite monitoring experience as a Clinical Research Associate (CRA)
• 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.