Inhouse Clinical Research Associate – Australia

Novotech; Brisbane; Sur place; AUD 70 000 - 110 000; Plein temps

Résumé du poste

Novotech is seeking an Inhouse Clinical Research Associate to support the clinical team in Australia. The role involves coordinating TMF, maintaining site documentation, and assisting with essential document development in line with ICH GCP and SOPs.

You will manage the CTMS, monitor site milestones, assist with on-site or remote visits, and support IRB submissions during maintenance and close-out. Relevant life sciences experience is preferred.

Qualifications

• Qualification in Life Sciences or related field.
• At least 1 year of in-house CRA or clinical admin experience.

Responsabilités

• Support in-house clinical activities on assigned projects.
• Coordinate and maintain TMF documentation including audits.
• Assist in essential document development and translations.
• Manage CTMS and ensure site milestones and data accuracy.
• Prepare Investigator Site Files and manage study materials.
• Assist with onsite or remote monitoring visits.
• Support IRB submission and tracker management during maintenance and closeout.

Connaissances

Life Sciences

GCP Knowledge

Clinical Administration

Formation

Life Sciences degree

Outils

CTMS

TMF Tracking

IRB Submissions

Description du poste

Novotech is seeking an Inhouse Clinical Research Associate to support the clinical team in Australia. The role involves coordinating TMF, maintaining site documentation, and assisting with essential document development in line with ICH GCP and SOPs.

You will manage the CTMS, monitor site milestones, assist with on-site or remote visits, and support IRB submissions during maintenance and close-out. Relevant life sciences experience is preferred.