Clinical research associate

Job highlights

• Assist with preparation of required regulatory submission liaising with DRA team. .

JOB DETAILS
One of our clients, a reputed company in clinical research, is looking out for a Clinical Research Associate for their office based in Mumbai. The job responsibilities are as follows:

1. Act as monitor of specific sites on a clinical study, under supervision, as appropriate.
2. Facilitate preparation and collection of site level documents.
3. Participate in trial site training activities, as assigned.
4. Perform monitoring visits according to monitoring plan, as assigned, including source document verification.
5. Facilitate site drug supply management.
6. Co-ordinate site level updates of technical systems (ClinAdmin, EDC).
7. Ensure site activities in line with milestones (i.e. startup, recruitment, closeout, etc).
8. Demonstrate and apply GCP and ICH requirements.
9. Prepare study monitoring reports under supervision, as appropriate.
   9.Assist with data query resolution process (both at Site and in-house with Data Management).
10. Perform Site Closeout activities.
11. Under the guidance of Senior CRA/CRA Group Head perform IM related activities like logistics, preparation of IM binders and technical presentations.
12. Assist with preparation of required regulatory submission liaising with DRA team.