Clinical Research Associate (CRA) - Adelaide
Melbourne, Victoria, Australia · Kontrak
Jadilah yang pertama mendaftar
- Pengalaman
- 5–7 yrs
- Gaji
- —
- Lowongan
- 1
- Diposting
- 1 bulan yang lalu
- Mode kerja
- Di kantor
- Pendidikan
- Gelar sarjana
- Kelayakan
- Professionals with the required science, nursing, medical, or pharmacy background and 5 to 7 years of CRA experience in a CRO, biotech, or pharmaceutical environment may apply.
- Melanjutkan
- Wajib mendaftar
Tempat Anda akan bekerja
Deskripsi pekerjaan
Role overview
This contract Clinical Research Associate position supports clinical studies across Melbourne, Adelaide, and Perth. The assignment is set at 0.5 to 1 FTE, starts as soon as possible, and runs for 12 months. The role focuses on ensuring that study activities are carried out in line with the clinical protocol, standard operating procedures, Good Clinical Practice, and all other relevant regulatory obligations.
Key responsibilities
- Carry out site monitoring independently, including site selection/evaluation, initiation, interim, motivational visits where needed, and close-out visits.
- Write and submit monitoring visit reports in line with internal procedures.
- Support co-monitoring activities at investigational sites when required.
- Collect, organize, and maintain essential trial documentation according to SOPs.
- Share study-related information between trial sites and the project team, and keep a record of all communications.
- Flag and escalate issues promptly so they can be addressed by the wider team.
- Oversee important study activities such as start-up work, clinical supply preparation, recruitment, data capture, and site close-out.
- Educate site staff on the protocol, related plans, manuals, guidance materials, and relevant industry standards, including ICH-GCP.
- Provide training to site teams on study-specific systems or vendor platforms when applicable.
- Review trial data and resolve inconsistencies or mismatches.
Experience and education
A bachelor’s degree or comparable professional experience is needed, with a background in science, nursing, medicine, or pharmacy required. The employer is looking for someone with 5 to 7 years of prior CRA experience gained in a CRO, biotech, or pharmaceutical setting.
Skills and knowledge
The role calls for strong knowledge of clinical research standards, regulatory requirements, and ICH-GCP. The candidate should also be comfortable traveling extensively and working within study-specific billing and budget limits.
Additional information
Work locations include Melbourne, Adelaide, and Perth. The position is available at 0.5 to 1 FTE. The expected start is ASAP, and the contract duration is 12 months.