Clinical Research Co-ordinator

As a Clinical Research Coordinator at Analytical Project, St. John's Research Institute in Bangalore, you will be responsible for interacting with patients, sponsors, IEC, lab staff, and other departments to conduct studies following ICH GCP Guidelines, SOPs, and study protocol guidelines. You will act as the main communication line between patients, Investigators, and CROs during study conduct activities. **Key Responsibilities:** - Coordinate in screening, Audio-Video consenting, enrolment, periodic study visits, and close out visits. - Ensure the protection of the rights and well-being of research participants throughout the study duration. - Coordinate with finance, legal, and regulatory teams to prepare CTAs specific to the trials. - Maintain study documentation by completing source documents for each patient and updating Site Master Files. - Complete CRFs and e-CRFs on time, as well as resolve data queries. - Handle EDC, Inform & Medidata data capture. - Maintain inventory of study consumables including Investigational product handling, storage, dispensing, accountability, temperature tracking, equipment calibration, sample centrifugation, courier of documents, and lab sample shipment. - Prepare, notify, and track Ethics committee submissions in a timely manner. - Submit study progress, amendments, Protocol Deviations, AE's, and SAEs to the ethics committee and sponsor promptly. - Coordinate with the investigator and safety monitoring team during SAEs. - Assist in resolving IEC, DCGI, and FDA queries. - Coordinate and participate in monitoring visits with sponsor/CRO and facilitate inspections/audits. - Follow up with patients, document telephone contacts, conduct study closeout visits, and archive documents. - Maintain records of closeout studies and resolve post-closeout queries. **Qualifications Required:** - Degree with a life Science background. - Trained in Clinical research e.g. Diploma in Clinical research or MSc Clinical research and Pharm D. - Experience: 0-6 months. - Language proficiency in English, Kannada, Hindi, and Telugu. Interested candidates are encouraged to send their resume to The Principal Investigator at Analytical Project, St. John's Research Institute by emailing a cover letter and curriculum vitae with 3 references (names, email addresses, and phone numbers) to molly.j@sjri.res.in & cc to hr@sjri.res.in by or before 28th August 2025. [Please note: For more information, please visit our website www.sjri.res.in],