Clinical Research Associate Job Openings – Thailand – Navitas Lifesciences
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.
