My client has launched a new clinical operating model to drive effectiveness, reduce hand-offs and increase employee, client and site satisfaction. Within this model, the Clinical Site Manager (CSM), formerly the Clinical Research Associate (CRA), serves as the clinical sites’ direct point of contact.
•Offers the opportunity to go beyond the role of a typical clinical monitor.
•Accountable for using expertise to build and maintain the site relationship and ensure they are set up for success.
•Address and resolve site issues and questions.
•Manage site quality and delivery from site identification through to close-out.
•Less travel and a lower protocol load in comparison to industry peers.
•Hard work will be rewarded through:
- a bonus incentive program,
- the opportunity to work within multiple therapeutic areas,
- and an opportunity to advance your career in clinical research.
•Act as sole contact with assigned clinical sites
•Use your trial management expertise to oversee overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staff
•Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; generate visit/contact report
•Review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are protected and are in accordance with protocol
•Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability
•Develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines •Ensure compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s)
•Monitor completeness and quality of Regulatory Documentation and perform site document verification
•Substantial Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
•Educated to degree level (biological science, pharmacy or other health related discipline)
•Demonstrates 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
•Client focused approach to work; flexible attitude with respect to work assignments and new learning
•Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s)
•Work ethically and honestly 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