About the position
We have an exciting new opportunity in our Clinical Research Associate Group and are seeking a committed, adaptable and driven individual with experience ensuring the rights and wellbeing of trial participants are protected and the reported trial data are accurate The Clinical Research Associate (CRA) is also the primary link between Investigational Sites and Sponsor, acting as a site manager ensuring that clinical trials are conducted and documented as per ICH GCP guidelines, local and global regulatory requirements

Experience and Qualifications

• Monitoring of investigational sites as per ICH GCP §5.18 (Monitoring) and the Clinical Monitoring Plan for each study. Specific duties include:
  • Site Selection: Assist Project Manager (PM) with identification, site feasibilities, and selection of investigational sites.
  • Ethics & Regulatory Submission: In collaboration with the CTA and Novotech's Regulatory Operations Group, prepare site essential documents, and participate in the ethics and regulatory submission and approval processes.
  • Study Initiation: Train investigators on the sponsor and regulatory requirements for conducting the study. Ensure the site has all supplies to perform the trial. Participate in Investigator Meetings as appropriate, including preparing and presenting presentations
• Provide written and verbal site updates (including monitoring visit reports) on study progress to the PM according to the study requirements/timelines as documented in the Clinical Monitoring Plan and Sponsor/Novotech SOPs.
• In collaboration with the CTA, co-ordinate transfer of data and documents between site, Novotech and sponsor, i.e. CRF pages, data queries and essential document transfers as per sponsor requirements.
• Assist with the development and update of systems to track study progress as per the PM requirements, i.e. CRF & query flow, safety reports, regulatory documents, contact records, investigator payments etc. Provide updates on study progress to LCRA/PM as required by the CMP / study Communication Plan.