R&D - Clinical Trial Administrator | Vaccine Industry

Job Title : Clinical Trail Administrator

Function: R&D - Clinical Development

Job Location : Corp. Office, Jubilee Hills, Hyderabad

Role & responsibilities

1. Assist with the Ethics / Regulatory Submissions; keep a track of submissions & approvals for the study.

2. Help medical team in preparing Protocols, Investigator Brochures and CRFs which includes keeping track and re-ordering supplies.

3. Set up and maintenance of the Trial Master Files (TMF) or Electronic filing systems/ set up of the Investigator Site File (ISF)/Site Master Files (SMF).

4. Managing and maintaining study documents & trial supplies e.g.; Patient/subject Information Sheets, Patient/subject Diaries, Source document templates, Lab Kits, Drug supplies & Medical equipment for sites.

5. Preparing essential clinical trial documentation, distributing, tracking and filing of documents on return.

6. Tracking of budget utilization, processing invoices & tracking payments for the trial for investigator payments.

7. Coordinating archiving of documents pertaining to Clinical Development.

8. Arranging translation of patient/subject documents.

9. Coordinate in investigational and control vaccines procurement activities.

10. Drafting clinical trial documents (Source documents, IB affidavit, Sponsor undertaking for compensation, SOC and protocol overview PPT).

Responsibilities as Clinical Data Management coordinator:

11. Assist in reviewing Clinical Data Management documents (eCRF, DMP, Edit Checks & Database).

12. Conducting eCRF testing using dummy data to validate system functionality.

13. Coordinate in eCRF query management and database lock.

Additional responsibilities:

14. Assist CRAs in monitoring activities for Clinical study sites

Candidate desired skills :

Good Communication Skills and should have hands on experience in Clinical trials.