We are currently seeking a Senior Clinical Research Associate to join our growing team
The role will include the following:
- Working in accordance with ICH E6 principles and with applicable SOPs
- Conduct of Feasibility assessments
- Project set up activities
- Conduct of site selection activities
- Negotiation and facilitating Investigator/site contract execution
- Development and local adaption of study specific documentation
- Set up of the trial master file
- Project conduct
- Maintenance of TMF
- Facilitating Regulatory submission
- Prepare, conduct and participate in Investigator s meeting
- Conduct Site initiation and site monitoring
- Maintain communication with study teams at site
- Maintain communication with clients and vendors as back-up for a project manager/project team lead based on the requirements
- Resolution of site level issues and where necessary escalation of issues to PM
- Support PM/PTL with project updates
- Participate in client meetings/teleconferences and inter-departmental meetings
- CRF retrieval and Query turnaround
- Project closeout
- Conduct site closeout visits
Desirable Skills and Experience
- A minimum of 3 years monitoring experience
- Robust knowledge of GCP principles and related local regulations
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📌 Marketing Surveillance (Bengaluru)
🏢 Navitas Life Sciences
📍 Bengaluru
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