Umar Farooque Shaikh Email & Phone Number

Aurangabad, Mh, In

Aurangabad, Maharashtra, India

Aurangabad, Maharashtra, India

• Coordinate all aspects of clinical research studies from initiation to closeout.• Ensure compliance with regulatory guidelines and institutional policies.• Screen, recruit, and enroll eligible participants according to study protocols.• Obtain informed consent from participants.• Input clinical research data into electronic systems accurately and on time.• Maintain thorough documentation of study protocol and update as needed.• Archive case report forms and related documents properly.• Schedule study visits, perform assessments, and collect data.• Communicate effectively with study participants, principal investigators, sponsors, and other team members.• Act as a resource for study participants, answering questions and explaining procedures.• Coordinate patient visits and procedures related to research.• Coordinate with all study sites, sponsors, ethics committee, and PI for smooth conduct of study.• Ensure the study site complies with all local and federal laws and regulations.

Aurangabad, Maharashtra, India

• Co-ordinate with SMOs’ CRCs for EC Submission.• Schedule Ethics Committee Meeting.• Prepare EC Meeting Agenda & Minutes of the Meeting.• Prepare EC approval of presented proposals.• Prepare Query Letters • Record Management & Maintenances of Ethics committee files of Clinical Trials Studies• Conduct Quality Audit of ongoing studies.• Prepare Ethic Committee Standard Operating Procedure.• Conduct Training on EC SOP.• Submit EC Meeting Status report to DCGI.• Communicate to DCGI and CDSCO in case of SAE's.• Schedule on-site EC monitoring visits and assist monitors with monitoring. • Follow-up & update of payment of presented protocol.

Aurangabad, Maharashtra, India

• Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the PI/ Investigator• Maintaining clinical trial-related documents at the site, including the Trial Master File.• Preparing for, facilitating, and assisting at site monitoring visits, protocol-prescribed, and other necessary patient visits, QA visits, sponsor visits, and Inspections. • Reporting site performance metrics at a pre-determined frequency. • Coordinating submissions to the ethics committee of protocol, adverse events, and periodic study reports for review and ensuring that all documentation to and from the ethics committee is appropriately maintained.• Assisting in scheduling patient investigations and assessments per instructions of the Principal Investigator • Assuring that all work at the site prescribed by the approved protocol, the contract, and the EC is performed in a timely and comprehensive manner• Transcribing source documents if required under the supervision of the PI or designated person and ensuring that they are reviewed and signed off by the responsible person. • Assisting in the timely resolution of data queries• Coordinating and supporting the timely completion of protocol-related procedures by the PI, specifically subject scheduling, subject screening, and enrollment• Maintaining regular contact with the site monitor regarding patient enrollment, visit scheduling, dosing/ dispensing • Facilitating cordial and timely communication between investigator and sponsor/ CRO• Supporting patient awareness, training, or other events at the site or in the neighborhood• Supporting data collection activity at the site including but not limited to feasibilities, epidemiological data, Coordinating and supporting the training team as and when required.• Providing oversight to other Site Solutions Executives at other site locations across India on the above activities

Aurangabad, Maharashtra, India

•To coordinate and facilitate all Clinical trial activities at the site, ensuring compliance with the protocol, applicable GCP guidelines, and local regulations•To support the Principal Investigator (P1) and site study team, assuring that the clinical trial(s) being conducted meet all the criteria set by the sponsors and regulators1. Performs timely data entry of the Case Record Forms (CRF) or Electronic CRF (eCRF) in consultation with the Pi/Investigator2. Maintaining clinical trial-related documents at the site, including Trial Master File.3. Preparing for, facilitating, and assisting at site initiation, monitoring and close-out visits, protocol-prescribed and other necessary patient visits, QA visits, sponsor visits, and Inspections.4. Reporting site-performance metrics at a pre-determined frequency5. Coordinating submissions to the ethics committee of protocol, adverse events and periodic study reports for review and ensuring that all documentation to and from the ethics committee is appropriately maintained 6. Assisting in scheduling patient investigations and assessments per instructions of the Principal Investigator7. Ensuring timely availability of IP and Lab kits and other clinical trial supplies and ensuring IP is appropriately stored, maintaining temperature logs where necessary, also maintaining IP accountability and accurate record of all clinical trial supplies including lab kits; dispensing of IP to subjects per the protocol under the supervision of the Pi8. Assuring that all work at the site prescribed by the approved protocol, the contract, and the EC is performed in a timely and comprehensive manner9. Organizing and coordinating laboratory sample pick-ups and reporting10. Transcribing source 10 documents if required under the supervision of the Pi or designated person and ensuring that they are reviewed and signed off by the responsible person

Master'S Degree, Clinical Research

Bsc. Perfusion Technology, Cardiopulmonary Technology/Technologist, A