<p>Responsible for coordinating and performing (if applicable) the collection, distribution and storage/ archival of data/ study material/ study supply generated (for assigned studies) during clinical research trials.</p> <ol start="2"> <li> <p>Responsible to ensure that the assigned trials stay on track with applicable regulations, GCP, Protocol and Tech Observer/ Sponsor SOP's.</p> </li><li> <p>Maintain databases of patient information; collect information for grant proposals and write correspondence.</p> </li><li> <p>Maintain Investigator database and search new potential Investigators for upcoming trials.</p> </li><li> <p>Enter data from forms and documents into databases as required for assigned studies.</p> </li><li> <p>Provide assistance to operational team by organizing files, projects, data and keeping it up to date for assigned studies.</p> </li><li> <p>Maintain Trial Master File (TMF) in coordination with APM/PM for assigned studies.</p> </li><li> <p>Assist CRA for the maintenance of the Site Master File ( SMF)</p> </li><li> <p>Assist with routine in-house data verification and quality control, ensuring data integrity and consistency with prescribed study protocol for assigned studies.</p> </li><li> <p>Use Standard Operating Procedures (SOPs) concepts, practices in a time sensitive manner.</p> </li><li> <p>Assist CRA in investigator meeting preparation, liaison, presentations, and follow up for assigned studies.</p> </li><li> <p>Assist CRA in tracking the Investigator site payment and liaise with sites for follow up on open issues, recruitment status update, required documents for TMF & resolution of open queries in CRF. Ensure timely submission of protocol / consent documents for EC/IRB approval. Including follow up for the approval status from site personnel for assigned studies</p> </li><li> <p>Communicate progress of study and relevant information to Project Manager/ CRA and other project team members as requested for assigned studies.</p> </li><li> <p>Assist CRA in archiving of study files on completion of a clinical trial.</p> </li><li> <p>May coordinate with vendors involved in a clinical trial as requested for assigned studies.</p> </li><li> <p>Other responsibilities as delegated by the Project Manager (PM)/ Assistant Project Manager (APM</p> </li></ol>