Clinical Research Associate

6 months ago


Dhule, India Vertex Business Solutions Full time

A Clinical Research Associate (CRA) plays a crucial role in the field of clinical research, ensuring that clinical trials are conducted in compliance with regulatory requirements and ethical standards. The primary responsibility of a CRA is to monitor and manage the progress of clinical trials at various investigational sites. Here is a typical job description for a Clinical Research Associate:
**Key Responsibilities**:

- **Site Selection and Initiation**:

- Participate in the selection of investigational sites and conduct site initiation visits to train site staff on study protocols, regulatory requirements, and data collection procedures.
- **Monitoring and Quality Assurance**:

- Conduct regular site visits to monitor study progress, review source documents, verify data accuracy, and ensure protocol compliance.
- Identify and resolve any issues or discrepancies in real-time, providing guidance to site staff to maintain data quality and trial integrity.
- **Regulatory Compliance**:

- Ensure that all activities related to the clinical trial are conducted in compliance with regulatory requirements, Good Clinical Practice (GCP), and relevant Standard Operating Procedures (SOPs).
- **Data Management**:

- Collaborate with the data management team to review and verify clinical trial data, ensuring accuracy, completeness, and consistency.
- Assist in resolving data discrepancies and contribute to the maintenance of the trial database.
- **Safety Monitoring**:

- **Monitor and report adverse events and serious adverse events in accordance with regulatory requirements and study protocols.
- Collaborate with safety monitoring committees and regulatory authorities as needed.

**Qualifications**:

- Bachelor's degree in a relevant field (life sciences, nursing, etc.); advanced degree is a plus.
- Previous experience as a Clinical Research Associate or in a related role.
- Strong knowledge of GCP, regulatory guidelines, and clinical trial processes.
- Excellent communication and interpersonal skills.
- Attention to detail and strong organizational skills.

**Salary**: ₹25,068.54 - ₹30,786.29 per month

**Benefits**:

- Cell phone reimbursement
- Flexible schedule
- Health insurance
- Internet reimbursement
- Provident Fund

Supplemental pay types:

- Joining bonus
- Performance bonus
- Yearly bonus

Ability to Commute:

- Dhule, Maharashtra (required)

Ability to Relocate:

- Dhule, Maharashtra: Relocate before starting work (required)

Work Location: In person

**Speak with the employer**

+91 9860689000


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