Navitas Life Science Job Vacancy – Clinical Research Associate
They are currently seeking a Senior Clinical Research Associate to join our growing team. In the role you will be responsible for:
Job Title: Associate Clinical Research
Location: Bangalore, India
Eligibility: Background of Chemistry, Medicine, Pharmacy, or similar qualification
- Working in accordance with ICH E6 principles and with applicable SOPs
- Accompanied visit as a part of mentoring a new CRA
- 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
- Resolution of site-level issues and where the necessary escalation of issues to PM
- Support PM/PTL with project updates
- Participate in client meetings/teleconferences and inter-departmental meetings
- Support in vendor selection, agreement, and co-ordination
- CRF retrieval and Query turnaround
- Facilitate site payments
- Project closeout
- Reconciliation and archival/disposal of study documentation
- Reconciliation and disposal/destruction of Investigational products
Conduct site closeout visits - Training: Participate/conduct training periodically as assigned by the project manager
Participation in other department initiatives/activities
Desirable Skills and Experience
- Clinical Trial Monitoring Onsite in Phase II-IV studies
- Experience in working in Multiple Indications and good understanding level
- Good working knowledge of Microsoft Office including Word, PowerPoint, and Excel
- Good understanding of GCP and Indian Regulatory
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