Clinical Research Coordinator -ATLAS-NEO

Job Summary

Bangalore

Interaction with Patients, Sponsor/CRO, IEC, Lab staff and other departments in the institution and conduct the study according to ICH GCP Guidelines, SOPs and study protocol guidelines and act as the main line of communication between patients, Investigators and CROs in study conduct activities.

Assist in Feasibility questionnaires, Coordinate in pre-site selection visit, site initiation visit.

Assist the Principal Investigator and Co investigators in screening of subjects by maintaining and updating the list of potentially eligible patients for the ongoing studies

Vacancy: One

Key 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

Eligibility Criteria

Preferred Qualifications:

Degree with life Science background, trained in Clinical research eg Diploma in clinical research , or MSC Clinical research and Pharm D

• Minimum Experience : 1 year, Fresher can also apply

Preferred Language: English, Kannada and Hindi Telugu