Clinical Research Associate Ii

14 hours ago

Ahmedabad, India Cliantha Research Full time

**Clinical Research Associate II - Clinical Trial**

Department Clinical Trials

Designation Clinical Research Associate II

Basic qualification B. Pharm / M. Pharm / M. Sc.
required
Experience 2 - 4 Years - Site monitoring

Location Ahmedabad

Brief JD
1. Identify and qualify potential investigators to ensure that the sites have adequate

time and can fulfill their obligation to the study.
2. Responsible for identification & collection of necessary documents to be forwarded

to Project Manager/ designee, in order to check the feasibility of site/ investigator
and approval from authorities.

3. Prepare or submit or support other colleagues for Regulatory and EC submissions
and in the generation of Financial Agreements according to standard and local
country practices.

4. Negotiate study budgets with investigators and ensure that timely payments are
made to the site as per guidance from Project Manager.

5. Responsible for training of site study team regarding the monitoring plan, recording
& maintenance of essential documents and for start up activities & site initiation as
per the guidance of Project Manager.

6. Assist for the preparation and presentation at investigator meetings, as required to
ensure that the clinical and investigational site staff team are well informed about
the study and related procedures.

7. Conduct of monitoring visits as per monitoring plan in order to check compliance
with study management, protocol & other requirements at all assigned sites.

8. Maintaining a working copy of Central Investigator File & ensuring consistency with
the Site Investigator File in order to maintain a working record of all essential
documents and reports.

9. Perform source document verification as per monitoring plan and ensure that
source documents & other trial records are accurate, complete, kept up-to-date &
maintained according to applicable SOP's to avoid incomplete records.

10. Ensure timely collection of documents like CRF, DCF etc from the site along with
SAE reports in order to provide Biometrics/licensing authority & others with the
necessary documents.

11. Responsible for study updates & Coordination with Labs & other trial related
services as per the study requirements.

12. Responsible for IP accountability and availability, tracking and management of all
Clinical Trial related supplies shipped to the sites/ warehouse & accordingly clinical
trials supplies vendor management for the study.

13. Ensure proper escalation of site/project related issues to Project Manager/
Designee on timely manner.

14. Responsible for site-closeout & follow up activities in order to maintain documents
at the site.

15. Attend staff meetings and training sessions as required to complete the training
curriculum in a timely manner.

16. Assist with the audit of an investigational site or central files and liase with Quality
Assurance personnel as required to ensure that the study is being conducted in
accordance with ICH GCP and applicable regulatory guidelines.

17. To liaise with other departments within the organization for timely achievement of
the project milestones.

18. Ensure to follow and adherence of organization’s general rules, policies and
applicable SOPs.

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