About this role
<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Description</H2> </div><div><table style="width:479.8pt" border="1" cellspacing="3" cellpadding="0"> <tbody> <tr style="height:84.65pt"> <td style="width:315.1pt"> <ul> <li>Travel to site and monitor the clinical trial data generated at sites to make sure that ICH GCP guidelines, study protocol and applicable regulations are being followed.</li> <li>Take lead on study activities and perform co-monitoring visits with CRAs to support and guide them as per the requirements.</li> <li>Preparing site visit reports within timelines</li> <li>Ensure that site staff is qualified, experienced, and adequately trained to perform their role and responsibilities. </li> <li>Ensure study data collected is accurate and verifiable.</li> <li>Manage clinical trial site payments and handle any ongoing negotiations.</li> <li>Ensure that the site has acceptable infrastructure and that it continues to remain so throughout the study.</li> <li>Act as a mentor to site staff and provide continuous support and guidance as required.</li> <li>Ensure study documents are appropriately maintain in their respective files till archival</li> <li>Adheres to protocol, regulatory requirements, good clinical practice, and standard operating procedures.</li> <li>Assesses the trial site and applicable personnel on an ongoing basis.</li> <li>Ensures compliance with the patient-consent process and other study procedures.</li> <li>Verifies the receipt, handling, accounting, storage conditions, and availability of clinical trial material. Verifies compliance and quality of collected study data. </li> <li>Ensures compliance with the procedures to apply in the event of serious adverse events.</li> <li>Prepare an appropriate intervention plan to avoid redundant errors and deviations.</li> <li>Verifies investigator site files and ensure it is consistent with in-house files.</li> <li>Any other assigned task/activities as per the need of study and organization to be completed.</li> </ul> <p> </p> </td> </tr> </tbody> </table> <p> </p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Work Experience</H2> </div><div><p> 4-5 years of Monitoirng experience in Sponsor/ CRO setting </p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Education</H2> </div><div><div>Graduation</div><div>Post Graduation in Pharmacy</div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Competencies</H2> </div><div><div>1. Strategic Agility</div><div>3. Customer Centricity</div><div>5. Result Orientation</div></div></div></div>