Clinical Research Associate

3 months ago

Vasanth Nagar Bengaluru Karnataka, India Sankalp India Foundation Full time

**Job Summary**:
**Key Responsibilities**:

- Oversee the progress of multiple clinical studies, ensuring adherence to study protocols, regulatory guidelines, and organisation's procedures.
- Conduct regular site visits to monitor the progress of clinical trials, verify data accuracy, and ensure proper implementation of study protocols.
- Ensure that all studies are conducted in compliance with GCP (Good Clinical Practice), ICH (International Conference on Harmonisation) guidelines, and applicable local regulations.
- Review and verify the accuracy and completeness of clinical data collected from study sites. Address any data discrepancies or issues promptly.
- Provide training and support to site staff and investigators on study protocols, procedures, and documentation requirements.
- Maintain comprehensive and accurate study documentation, including source documents, regulatory documents, and study files.
- Identify and address issues or deviations from the study protocol. Work with site staff and project teams to develop and implement corrective action plans.
- Serve as the primary point of contact between the study sites and the sponsor. Facilitate effective communication and coordination to ensure smooth study operations.
- Prepare and submit monitoring reports, progress updates, and other required documentation to stakeholders and regulatory bodies.

**Qualifications**:

- Minimum bachelor’s degree in life sciences or a related field. Masters preferred. Advanced degrees or certifications (e.g., Clinical Research Coordinator (CRC), Clinical Research Associate (CRA)) are a plus.
- Minimum of 5 years of experience as a CRA or in a similar role, with demonstrated experience managing multiple studies simultaneously.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements. Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS) is preferred.
- Excellent organizational and time management skills, with the ability to manage multiple priorities and deadlines. Strong analytical, problem-solving, and communication skills.
- Willingness to travel frequently to study sites as required.

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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