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Clinical Research Associate
IQVIA IndiaBengaluru, Karnataka, India19 days ago
Job descriptionBachelor's degree in a scientific discipline or healthcare preferred. Equivalent education, training, and experience may be accepted. Completion of CRA training program or prior monitoring experience preferred. Basic knowledge of clinical research regulatory requirements (GCP and ICH guidelines). Proficiency in Microsoft Word, Excel, PowerPoint, and use of laptops and mobile devices. Strong written and verbal communication skills in English. Excellent organizational, problem-solving, and time management skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Job Titles : : CRA I / CRA II / Senior CRA
Locations : : Any metro location in India
Therapeutic Area Experience : : Any biopharmaceutical and minimum 2 years of on site monitoring experience
Job Overview :
Perform monitoring and site management to ensure compliance with study protocols, regulations, guidelines, and sponsor requirements.
Essential Functions :
- Conduct site monitoring visits (selection, initiation, monitoring, and close-out) per GCP and ICH guidelines.
- Adapt, drive, and track subject recruitment plans to meet project needs.
- Provide protocol and study training to sites and maintain regular communication.
- Evaluate site practices for protocol adherence and escalate quality issues.
- Track study progress, including regulatory submissions, recruitment, CRF completion, and data queries.
- Ensure site documents are filed in the Trial Master File (TMF) and Investigator's Site File (ISF) per GCP / ICH and local regulations.
- Document site management, visit findings, and action plans through reports and follow-up letters.
- Collaborate with study team members for project support.
- Support development of project subject recruitment plans and site financial management as needed.
Qualifications :