The Company

Our client is an Australian-owned boutique CRO providing full-service support to pharmaceutical, biotechnology, device companies and institutional research groups across Australia and beyond. With 25+ years of operational and industry experience, they work across therapeutic areas including first-in-human studies, devices, endocrinology, oncology, neurology, gastroenterology, rare and paediatric diseases, and vaccines. Their expertise spans academic, commercial and biotechnology settings, supporting projects from Phase I to Phase III.

The Opportunity

Due to continued growth, our client is seeking an experienced CRA within Australia. You may currently be a Senior or Principal/Lead CRA looking for a change of scene, new challenges, or an improved work-life balance as a CRA.

- Lead the identification, qualification, and selection of investigators and trial sites, including conducting feasibility assessments.
- Oversee full site lifecycle management (pre-study, initiation, monitoring, and close-out) to ensure optimal site performance.
- Ensure 100% compliance with ICH-GCP, local regulations (e.g., TGA, NHMRC, Medicines Australia), and internal QMS requirements.
- Conduct monitoring visits and perform source data verification (SDV) in line with the study monitoring plan to ensure data integrity and patient safety.
- Prepare monitoring reports, maintain Trial Master File (TMF), and ensure accurate, complete, and timely documentation.
- Train investigators and site staff on protocol, GCP,



and regulatory requirements, and ensure ongoing compliance and competency.
- Support ethics and regulatory submissions, site start-up activities, and ensure all essential materials and approvals are in place.

The Requirements

- 7-10+ years' experience as a CRA or in a closely related clinical trial monitoring role.
- Strong expertise in clinical monitoring and site management.
- Excellent attention to detail, a strong focus on data integrity, and the ability to manage competing priorities.
- Tertiary qualifications in science, health, nursing, or a related field, along with a current GCP certificate.
- Robust knowledge of ICH-GCP, TGA, NHMRC, and Medicines Australia guidelines.
- Highly developed communication, planning, organisational, and time management skills.
- Excellent written, verbal, and presentation skills.
- Able to work independently, identify issues, and escalate them with a proposed resolution plan.

The Opportunity You will be given direct responsibility to contribute to the success of innovative, life changing products, where the outcomes will be recognised globally. Position title and remuneration will reflect experience level and appointment of a Senior or Principal/Lead CRA will be considered. For more information, please email [email protected] or call 1300 063 932 to speak with our team.

Applications should include a cover letter addressed to Marilyn Jones or Mark Thomas and can be submitted online via our website at www.mexec.com

📌 Lead Clinical Research Associate (Australia)
🏢 mexec
📍 Australia