Clinical Research Manager

7 days ago

Alton Downs, Australia beBeeResearch Full time $95,000 - $110,000
Senior Clinical Research Associate

This is a critical role in driving better life outcomes for patients worldwide.

About the Position

The Senior Clinical Research Associate will oversee the execution of clinical trials ensuring adherence to applicable SOPs, regulations and ICH guidelines.

  • Collaborate with project teams to ensure efficient trial management.
  • Perform Site Qualification Visits: discusses protocol, other available study documentation and study requirements with Investigator and other trial staff, ensures that trial staff and site facilities and the site's recruitment potential are in accordance with protocol requirements, local regulations, ICH-GCP and GC CRO's SOPs
  • Support feasibility, site selection and start up activities, including leading the preparation of Human Research Ethics Committee (HREC) submissions with sites.
  • Negotiate site budgets and assists with the execution of site contracts with support from the Project Manager.
  • Perform Site Initiation Visits: trains Investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and GC CRO's SOPs.
  • Perform Interim Monitoring Visits: ensures adherence to protocol, monitor participant source data via source document verification per the monitoring plan, and perform Investigational Product accountability, meet with site staff and ensure study procedures are conducted in accordance with the protocol and Informed Consent Form GCP.
  • Perform Site Close Out Visits.
  • Oversee all aspects of study site management to ensure high quality data
  • Maintain eTMF filing.
  • Maintain study tracking in Clinical Trial Management System (CTMS) in a timely manner.
  • Manage timely site payments.
Key Requirements

To succeed in this role, you will need:

  • An Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
  • At least 3-4 years' experience in monitoring clinical trials in CRO (preferable), Pharmaceutical and/or Biotechnology industry as a SCRA/CRA.
  • Experience in managing early phase oncology trials is highly preferred
  • Experience in EDC & CTMS
  • Experience in all aspects of site-management from feasibility, start-up site selection to site close-out.
  • Experience in contract negotiation desirable.
  • Experience in HREC submission preparation.
  • Understanding and practical knowledge of ICH-GCP requirements particularly as required for site management.
  • A willingness to travel to fulfill the requirements of the role.

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