Opening for Clinical Research Coordinator

3 days ago

Chennai, India Apollo Research & Innovations Full time

Position - Ethics Committee Coordinator

Qualification - Life Science Graduate

Experience - Above 1 Years

Timing - General Shift

salary - 10K - 15K

Location - Chennai

Contact No:
+91-XXXXXXXXXX

Job Roles & Responsibilities:

- Responsible for the preparation of EC agenda, Synopsis, Meeting approval/Acknowledgement/notification etc. EC member related activities, EC SOP and any other EC related activities for Chennai Site.
- Responsible that the relevant documents are sent to the EC members within the time line as per EC SOP
- Responsible to ensure that EC members are informed for EC meetings, make sure that they are informed and reminded for the meeting, make arrangements for the vehicle and refreshment.
- Responsible to submit the documents for all Chennai trials to EC member secretary/EC vice chairman, get the signature and send back to relevant site with documentation.
- Responsible to ensure that synopsis is prepared for all the trials for EC review meeting in advance with details from clinicaltrials.gov and details on earlier study reports.
- Responsible to ensure that queries of EC members are sent to PI/sponsor for clarification and resolve before the next EC or at the next EC meeting.
- Responsible to ensure that the latest ICMR - revised schedule Y and ICMR guidelines are sent to the EC members.
- Responsible to report to Site Head and coordinate with other CRC for smooth completion of the Job. CEC & allocated responsibilities
- Responsible for the receipt of any document from CEC and submission of documents to CEC from Chennai site.
- Responsible for the preparation of EC synopsis for the trials from Chennai Site.
- Responsible to ensure to send the EC related documents to CED members immediately on receipt of the stake from CEC member secretary.
- Responsible to make sure to inform the availability of CEC members for the monthly CEC meetings.
- Responsible for the video-conference facility and refreshment for the CEC meeting along with the CEC study related documents.
- Responsible e to make list of AE/SAE of all the CEC studies for the meeting.
- Responsible to send the recommendations of CEC on receipt of the same from CEC.

Responsible to make sure that the Chennai CEC members and Chennai AHERF has a copy of the latest EC SOP and the membership details of the CEC along with the relevant guidelines

**_Job description: Ethics Committee Coordinator_**
- Verified documents submitted for acknowledgment
- Acknowledged and Approved EC documents
- Scanned EC acknowledged & approved documents
- Filed and Arranged member files for IEC-CS meeting
- Couriered EC documents to EC Members
- Pasting and Writing Minutes in minutes register
- Checked DNB Thesis for IEC-CS meeting
- Arranged study documents for IEC-CS meeting to EC members
- Informed EC members regarding confirmation of availability and reminder call on IEC-CS Meeting
- Verified and collected DNB Thesis IEC-CS Meeting
- Issued DNB certificate
- Drafted new protocols list for invoice
- Sending minutes to DMS office
- Coordinate with Doctors for submission of pending documents
- Coordinate to Archived IEC-CS Meeting and submissions documents
- Drafted and printed DNB Approvals for IEC-CS meeting
- Attended T Con
- Follow up with CRC’s
- NABH, JCI, Audit Requirement

**Salary**: ₹10,000.00 - ₹12,000.00 per month

Ability to commute/relocate:

- Chennai, Chennai - 600006, Tamil Nadu: Reliably commute or planning to relocate before starting work (preferred)

**Experience**:

- total work: 1 year (preferred)

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