Clinical Research Associate

5 days ago

Bengaluru, India NAVITAS LIFE SCIENCES Full time

Responsibilities & functions: Clinical Research Associate

  • Working in accordance with ICH E6 principles and with applicable SOPs (either ECRON AcuNova or Sponsor's SOPs) & local regulatory norms.
  • Review of study synopsis.
  • Site selection.
  • Preparation of Site feasibility questionnaire, conducting the feasibility and reporting to PM.
  • Preparation, conduct and reporting of site selection visits.
  • Negotiation & obtaining Investigator agreement on site budget, payment to the sites.
  • Development/Local adaptation of study specific documents (ICF, CRF prints, Study logs), translations of the documents.
  • Procuring essential documents from sites, their QC and filing in a timely manner and updating project tracker or sending the documents to PA for filing in a timely manner.
  • Maintenance of TMF and Site specific file.
  • Scanning & uploading documents into shared drive.
  • Transmission of documentation into project files.
  • Preparation of regulatory dossier, regulatory submission and follow-up.
  • Preparation of EC dossier, EC submissions and follow-up.
  • Co-ordinating arrangements for the investigators meeting, acting as a host for this meeting.
  • Development of meeting materials along with required presentations for investigators meeting.
  • Site initiation visit planning, preparation, conduct, report and follow-up of pending issues.
  • Co-ordinating the IP request between sites and pharmacist/vendor/sponsor.
  • Site monitoring visit planning, preparation, conduct, report and follow-up of pending issues.
  • Remote Monitoring, Central Monitoring and Risk Based Monitoring related activities.
  • Accompanied visit as a part of mentoring a new CRA.
  • Interacting with DM for data transfer and query resolution.
  • Interacting with MW for CSR appendices.
  • Preparation of project status report.
  • Preparations, participation in meetings and documentation of meeting minutes.
  • Provide oversight to project (maintaining quality & 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.

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