Clinical Research Associate II (FSP)

<p><b>When our values align, there&#39;s no limit to what we can achieve.</b><br /> <br />At Parexel, we all share the same goal - to improve the world&#39;s health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.</p><p>Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we&#39;re committed to making a difference.</p><p></p><p></p><p><span><span><b><span>Key Role and Responsibilities Summary:</span></b><i><span> </span></i><span> </span></span></span></p><ul><li><p><span><span><span>Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines. </span></span></span></p></li></ul><ul><li><p><span><span><span>Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of <br />clinical trials, and close clinical trials at investigative sites. </span></span></span></p></li></ul><ul><li><p><span><span><span>Reviews and verifies accuracy of clinical trial data collected, either on site or remotely. </span></span></span></p></li></ul><ul><li><p><span><span><span>Provides regular site status information to team members, trial management, and updates trial management tools, </span></span></span></p></li></ul><ul><li><p><span><span><span>Completes monitoring activity documents as required by SOPs or other contractual obligations. </span></span></span></p></li></ul><ul><li><p><span><span><span>Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues. </span></span></span></p></li></ul><ul><li><p><span><span><span>Escalates site and trial related issues per SOPs until identified issues are resolved or closed. </span></span></span></p></li></ul><ul><li><p><span><span><span>Performs essential document site file reconciliation. </span></span></span></p></li></ul><ul><li><p><span><span><span>Performs source document verification and query resolution. </span></span></span></p></li></ul><ul><li><p><span><span><span>Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites. </span></span></span></p></li></ul><ul><li><p><span><span><span>Verifies SAE reporting according to trial specifications and ICH GCP guidelines. </span></span></span></p></li></ul><ul><li><p><span><span><span>Communicates with investigative sites</span></span></span></p></li><li><p><span><span><span>Updates applicable tracking systems. </span></span></span></p></li></ul><ul><li><p><span><span><span>Ensures all required training is completed and documented </span></span></span></p></li></ul><ul><li><p><span><span><span>Serves as main observer/assessor of site activities. </span></span></span></p></li></ul><ul><li><p><span><span><span>Facilitates audits and audit resolution. </span></span></span></p></li></ul><ul><li><p><span><span><span>To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g. protocol amendment submissions, Investigator site budget negotiation. </span></span></span></p></li></ul><ul><li><p><span><span><span>Mentors’ junior-level CRAs and serve as a resource for new employees. </span></span></span></p></li></ul><ul><li><p><span><span><span>Serves as main observer of site activities and may have some responsibilities for performance of site. </span></span></span></p></li></ul><ul><li><p><span><span><span>May be assigned additional clinical operations tasks. </span></span></span></p></li></ul><ul><li><p><span><span><span>May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines. </span></span></span></p></li></ul><ul><li><p><span><span><span>May be assigned clinical tasks where advanced negotiating skills are required. </span></span></span></p></li></ul>