Clinical Research Associate Job Openings – Thailand – Navitas Lifesciences

clinical research associate job openings thailand858384618044947508

Are you looking for the new job opportunity as Clinical Research Associate (CRA)?. The great opportunity to Work with Navitas Lifesciences

Job Description
Navitas Lifesciences looking for a Clinical Research Associate. The successful candidate will:

  • Work in accordance with ICH E6 principles and with applicable SOPs (either Navitas Life Sciences or Sponsor’s SOPs) as well as local regulatory requirements
  • Carry out a review of study synopsis
  • Be involved in Site selection
  • Prepare Site feasibility questionnaire, conduct the feasibility and reporting to PM
  • Prepare, conduct and report based on site selection visits
  • Negotiate and obtain Investigator agreement on site budget, payment to the sites
  • Develop/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents
  • Procure essential documents from sites, their QC and filing in a timely manner and update project tracker or send the documents to PA for filing in a timely manner
  • Maintenance of TMF and Site-specific file
  • Scan and upload documents into shared drive
  • Transmit documentation into project files
  • Prepare regulatory dossier, regulatory submission, and follow-up.
  • Prepare EC dossier, EC submissions, and follow-up
  • Co-ordinate arrangements for investigators meetings, act as a host for required meetings
  • Develop meeting materials along with required presentations for investigators meetings
  • Site initiation visit planning, preparation, conduct, report and follow-up of pending issues
  • Co-ordinate the IP request between sites and pharmacist/vendor/sponsor
  • Planning, prepare, conduct, report, and follow-up on pending issues as a result of site monitoring visit
  • Carry out Remote Monitoring, Central Monitoring, and Risk Based Monitoring related activities
  • Carry out an accompanied visit as a part of mentoring a new CRA
  • Interact with DM for data transfer and query resolution
  • Interact with MW for CSR appendices
  • Prepare project status reports
  • Prepare and participate in meetings and the documentation of meeting minutes
  • Provide oversight to project (maintaining quality and timelines of deliverables)
  • Participate in client QA assessments
  • Reconciliation Filing of project correspondence
  • Site close-out visit planning, preparation, conduct, report
  • Maintenance of Investigator database and a QC of the database
  • Archival of study documentation Participation in other department initiatives/activities

Desirable Skills and Experience :

  • Experience in Clinical Monitoring is required

Work Experience : If you have at least 1+ year of onsite monitoring experience in Thailand, apply for the position in our Clinical Operations team. Should be familiar with Thai

For further information, contact Santhanalakshmi.S@navitaslifesciences.com with your updated resume if you are a candidate with a work permit in Thailand.

Apply Here
clinical research associate job openings thailand858384618044947508
Clinical Research Associate Job Openings – Thailand – Navitas Lifesciences

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