Clinical Research Associate

Job Description

We are 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

Thailand

Bachelor’s Degree in Pharma

Junior

Clinical Research

Full Time

18 Feb 2021