Clinical Research Co-ordinator

3 days ago

Bengaluru Karnataka, India St. John's Research Institute Full time

**Brief Description about the Project**

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.

**Clinical Research Co-ordinator**

No. of Vacancy:One

Preferred Qualifications**:Degree with 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**: English, Kannada and Hindi Telugu

**Salary**: Rs.30,000/- per month

**Location**: Bangalore

**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, AE's 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

The Principal Investigator

Analytical Project

St. John's Research Institute

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