Clinical Research Co-ordinator -Analytical

Roles and Responsibilities :

Coordinate in screening, Audio-Video consenting, enrolment, periodic study visits and close out visit.

• Ensure that rights and well-being of a research participant is protected throughout the duration of the study.
• Coordinate with finance, legal and regulatory team and assist in the preparation of CTAs specific to the trials.
• Assure all study documentation is maintained by completing the source documents for each
• Patient and maintaining and updating Site Master Files.
• Completing CRFs, e-CRFs on time and resolve data queries.
• EDC, Inform & Medidata data capture.
• Ensure and maintain inventory of Study consumables like Investigational product handling, storage, dispensing, accountability, tracking temperature, calibration of equipment s, sample centrifugation, courier of documents and lab samples shipment.
• Timely preparation, notification and tracking of the Ethics committee submissions.
• Submission of the study progress, amendments, Protocol Deviations, AEs and SAEs to the ethics committee and sponsor in a timely manner.
• Coordinate with the investigator and the safety monitoring team at the time of SAEs
• Assist in resolving IEC, DCGI and FDA queries.
• Coordinate and participate in monitoring visits with sponsor / CRO and Facilitating inspections / audits.
• Follow up with patients and document in telephone contact report.
• Conduct study closeout visit and archive the documents.
• Maintain record of closeout studies and resolve the post closeout queries

Skills Required

Data Analysis, Clinical Trials, Regulatory Compliance, Protocol Development, patient recruitment, statistical software, Project Management