Job Description
Responsibilities:
- Perform routine site visits, including Pre-study, initiation, routine and closeout visits. Visits to include monitoring or proper informed consent procedures, compliance and assurance of good site performance
- Document each visit with a quality written monitoring visit report and submit to the reviewer for review and approval within contractual guidelines
- Author and send follow up letter to investigative site documenting the visit and any outstanding items to be addressed within contractual timelines
- Review and approve monitoring visit reports ensuring finalization within contractual obligations
- Perform monitoring evaluation visits with Junior CRAs
- Competitive remuneration package with excellent benefits
Key Requirements:
- Bachelor's Degree or nursing credential
- A minimum of 3 year independent monitoring experience as a CRA in ANZ
- Extensive knowledge of GCP/ICH Guidelines and other applicable regulatory requirements
- Proven ability to work independently in a fast paced environment
- Strong communication, interpersonal and organizational skills
Please contact Chris Parkinson christopher.p.a2tui2b09@nesgt.aptrack.co.uk for more information or call on 02 9696 8005 for a confidential discussion