BriefCase
BriefCase

Clinical Research Associate/senior Cra Job in Navitas Life Sciences

Clinical Research Associate/senior Cra

Navitas Life Sciences 4+ weeks ago
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Job Summary
  • 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 & facilitating Investigator/site contract execution
  • Development & local adaption of study specific documentation
  • Set up of the trial master file
  • Project conduct
  • Maintenance of TMF
  • Facilitating Regulatory submission
  • Prepare, conduct & participate in Investigators 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 & where necessary escalation of issues to PM
  • Support PM/PTL with project updates
  • Participate in client meetings/teleconferences and interdepartmental meetings
  • Support in vendor selection, agreement and co-ordinatiion
  • CRF retrieval & Query turnaround
  • Facilitate site payments
  • Project closeout
  • Reconciliation & archival/disposal of study documentation
  • Reconciliation & disposal/destruction of Investigational products
  • Conduct site closeout visits
  • Training: Participate/conduct training periodically as assigned by the project manager
  • Participation in other department inititatives/activities.


Skills Required :
Clinical Trial Monitoring Onsite in Phase II-IV studiesExperience in working in Multiple Indications and Good understanding levelExperience in working in Solid tumor oncology studies
Qualification :
Life Science Graduate
Experience Required :

Fresher

Vacancy :

2 - 4 Hires

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