IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients. Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Sr CRA 1
Are you a Clinical Research Associate or Senior Clinical Research Associate looking for a new and exciting challenge with exposure to ongoing support and growth? Then we have the job for you!
IQVIA's Clinical FSP/Client Focused Department has new upcoming (S)CRA positions with our ongoing and newest clients across Australia As a CRA within this model you will be responsible for the following (but not limited to): :
Required skills and experience:
- Contribute to the identification of new sites for clinical trials; analyse capability and support CRMA and CSM in making recommendation for trial inclusion.
- Assume ambassadorial role to facilitate communication between sites and the client CPO to increase value proposition to investigators.
- Facilitate the preparation and collection of site and country level documents during all phases of the trial. Supports the CSM in the oversight of Country and Site Trial Master Files (TMF). During all phases of the trial ensure archiving per relevant SOP.
- Negotiate investigator remuneration; prepare financial contracts between the client and investigational sites and investigators.
- Ensure adherence to payment schedule.
- Execute site initiation and training, generate initiation visit report.
- Implement complete site management including monitoring visits, regulatory assessment, drug supply management, etc. to ensure compliance with protocol, GCP, global and local regulations, global and local processes.
- Identify problems at sites; resolve issues and escalate as appropriate.
- Collaborate with the CSM to ensure recruitment and execute contingency plans, as needed.
- Complete preparation and generation of visit monitoring reports as per relevant SOP
- Review and manage data at site; resolve technical and content issues on a continuous basis in order to achieve timely database lock targets.
- If working with central CRAs (blinded and un-blinded), respond to alerts and follow-up to ensure resolution of issues
- Implement site close-out activities and generate site close-out report.
- Provide feedback on site performance for future trial site feasibility/selection
- Bachelors Degree in Life Sciences or other scientific/nursing disciplines is essential
- Minimum of 2 years Clinical Research Associate experience, preferable within a CRO or Pharma
- Ability to travel on a regular basis which will involve interstate travel across ANZ
- Extensive knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines is required
- Oncology experience is highly desired
Should this position be of interest or should you know anyone who may be interested please submit a resume and cover letter
Please note these positions are only available to candidates who have current Australian Working Rights and live within the desired location
If you are suitable for this position a member of the Talent Acquisition team will be in contact to discuss your application
If you wish to hear more about these positions or any other positions IQVIA is currently advertising please reach out
Sydney +612 9016 8100
Melbourne +613 9519 6800
Auckland NZ +64 9440 6200
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.