Clinical Research Associate

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.