Clinical Research Associate

2 weeks ago

Bengaluru, India Sapthagiri Institute of medical sciences & research center Full time

This post is located at Sapthagiri Institute of Medical Sciences & Research Centre Campus and reports to the General Manager of Sapthagiri Clintrac Pvt. Ltd.,

**Key Responsibilities**:

- Assist the General Manager in writing Study Proposals, Study Progress Reports and Sponsor related requirements.
- Ensure the Clinical Trial Sites have adequate Trial materials, including the Trial Drugs often known as the Investigational Medicinal Product (IMP).
- Responsible for training Clinical Research Coordinators and site staff on therapeutic areas, protocol requirements, proper source documentation, and case reports form completion.
- Ensure compliance with SOPs and local regulations, and ICH and GCP guidelines.
- Monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis and dealing with Clinical Research Coordinators and solving any issues.
- Verify that the data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV).
- Collect completed CRFs from hospitals and general practices, write visit reports and file and collate trial documentation and reports, meet with team members to discuss on-going trials, results and any trends or adverse events.
- Ensure all unused trial supplies are accounted for close down trial sites on completion of the Clinical Trial.

**Requirements**:

- Master degree in Microbiology / Biochemistry.
- Preferably with 2+ years of experience as a clinical research associate.
- Knowledge of the pharmaceutical industry, terminology, and practices.
- Knowledge of ICH, ICMR and FDA regulations and their practical implementation.
- Strong verbal and written communication skills.
- Proficient computer skills.

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹240,000.00 - ₹250,000.00 per year

**Benefits**:

- Cell phone reimbursement
- Flexible schedule
- Food provided
- Internet reimbursement
- Paid sick time

Supplemental pay types:

- Overtime pay
- Performance bonus

Ability to commute/relocate:

- Bengaluru, Karnataka: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 1 year (preferred)

**Speak with the employer**
+91 7892196860

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