Inhouse Clinical Research Associate - Australia

Novotech; Brisbane; On-site; AUD 70,000 - 110,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

Life Sciences

GCP Knowledge

Clinical Administration

Education

Life Sciences degree

Tools

CTMS

TMF Tracking

IRB Submissions

Job description

Inhouse Clinical Research Associate - Australia

The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.

Responsibilities

• Support the clinical team's inhouse activities on assigned projects.
• Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.
• Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.
• Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements. Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF's, ensuring accuracy and completeness of the data.
• Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials (e.g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study. Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.
• May assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits.
• May assist IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close out phase.

Minimum Qualifications & Experience

• Relevant experience/qualifications in Life Sciences or related field or administration would be preferable. Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
• A minimum of 1 years experience as inhouse CRA or relevant clinical administration roles.