- Location
- Regional_Australia
- Workplace
- Remote
- Type
- Full-time
- Department
- Healthcare
- Seniority
- Entry
- Education
- Bachelor
- Source
- Workday
Description
You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.
We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.
Your ideas influence the way we work, and your voice matters here.
As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.
Join us and build your future here.
What you'll be doing:
- Delivers quality, timely monitoring reports for sponsor approval per the Clinical Monitoring Plan timelines
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements
- Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations
- Plans day to day activities for monitoring clinical study and sets priorities per site
- Prepares for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites as required by clinical monitoring plan.
- Monitors with knowledge of quality/scope/timeline and budget parameters
- Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member. Escalates appropriately and in a timely manner to the appropriate team member.
- Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) as defined by the organization’s processes per filing guidelines. Has an understanding of the required essential documents according to ICH/GCP Appendix C. Reviews site documents and verifies they are accurate, complete, current, and include required updates.
What we are searching for:
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
- Successful previous experience as a CRA with 4+ years’ experience in clinical trials; previous clinical research experience required, completion of CRA training program
- Experience in coaching/mentoring other CRAs
- Global experience preferred
- Experience in monitoring complex trials or global trials or equivalent experience
- Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
- Knowledge of web-based communication tools for conferences and any other IT systems required for the job
- Knowledge of clinical/health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site monitoring activities will be carried out
This position requires current working rights in Australia and is a fixed-term contract for 6 months.