Clinical Research Associate

2 days ago

Mira Road Thane, India Bio Scientific Research Laboratiories Pvt Ltd Full time

1) Preparation of SOP applicable for clinical department and to follow applicable SOPs.

2) Raise change control documentation for clinical SOP, Instrument and equipment

3) Performing quality checks ofrecords during screening check-in, in-house activity, check out and ambulatory compliance with protocol, ICH-GCP, SOP and regulatory guidelines requirements,

4) Review all logbooks, forms, as per SOP and regulatory requirements

5) Performing dosing activity.

6) Any other administrative or system related activity as assigned by HOD

7) Performing sample processing, sample segregation and transfer activity.

8) Review all of study documents (TMF, CRF, ICF etc.) for quality control.

9) Providing response to QA, sponsor, regulatory audit observations with CAPA.

**Salary**: ₹14,000.00 - ₹18,000.00 per month

Schedule:

- Day shift

**Education**:

- Master's (preferred)

**Experience**:

- total work: 1 year (preferred)

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