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

• Experience in Clinical Monitoring is required