Quality Assurance Clinical Research Associate

Eligibility:

1. Post Graduates in Life Sciences, Graduates/ Post Graduates in Pharmacy/Medical from a reputed Institute

2. At least 1-2 years experience as a Clinical Research coordinator.

3. Experience to include actual on-site monitoring of clinical trials, PSSVs, Site closeout visits, conducting feasibility studies.

4. Outstanding communication skills (both verbal and written) are a must to be successful in this role.

5. Demonstrated expertise in using the Microsoft Office products for presentations, documentations, spreadsheets.

Roles and Responsibilities:

1. Liaising with doctors/consultants (or investigators) on conducting the trial;

2. Setting up the study centres, which includes ensuring each centre has the trial materials and training site staff to trial-specific industry standards;

3. Monitoring the trial throughout its duration, which involves visiting the study centres on a regular basis;

4. Check the IP storage and the appropriate logs

5. Verifying that data. entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);

6. Review the Laboratory and patient data, Concomitant medications, AEs and SAEs, Regulatory reporting requirements and Notification letters to regulators/investigators/IRBs

7. Check the Drug Accountability

8. Ensuring all unused trial supplies are accounted for;

9. Discussing results with the study team leaders;

10. Preparing Follow up reports and letters,