Senior Clinical Research Associate

Job Description

We are currently seeking a Senior Clinical Research Associate to join our growing team. In the role you will be responsible for:

  • 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 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

Bangalore, India

Background of Biology, Chemistry, Medicine, Pharmacy, or similar qualification

Associate

Clinical Research

Full Time

23 Jul 2021