India Job Openings
Sankalp India Foundation
Clinical Research Associate (CRA)
FULL TIME
August 31, 2024
We are seeking a highly skilled and motivated Clinical Research Associate (CRA) to oversee and manage multiple clinical studies. The ideal candidate will ensure that studies are conducted in accordance with regulatory requirements, protocols, and organisation's standards, while maintaining high quality and integrity of the data collected.
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.
- 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)
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