CRA

Sironax; Australia; Remote; AUD 85,000 - 110,000; Full time

Job summary

Sironax is seeking a proactive Clinical Research Associate (CRA) to monitor and manage clinical trial sites across Australia. The role ensures adherence to the protocol, SOPs, ICH-GCP, and Australian regulations, interfacing with investigative sites and the clinical operations team.

The CRA will perform site management, SDV, IP accountability, and provide ongoing study process training to site staff, with frequent domestic travel (60-70%).

Qualifications

• University degree in Life Sciences, Pharmacy, Nursing or related field.
• Solid understanding of ICH-GCP guidelines and Australian regulatory requirements.

Responsibilities

• Perform on-site monitoring visits and monitor site performance.
• Ensure informed consent and protocol compliance.
• Conduct SDV to verify data accuracy and completeness.
• Manage IP accountability, storage and reconciliation at sites.
• Identify and resolve site issues, deviations and adverse events.

Skills

Site monitoring

Regulatory knowledge

Data verification

Communication

Education

Life Sciences degree

Tools

EDC

CTMS

Microsoft Office

Job description

We are seeking a proactive and detail-oriented Clinical Research Associate (CRA) to join our growing team. This role will be responsible for the on-site monitoring and management of one or more clinical trial sites within Australia, ensuring compliance with the study protocol, standard operating procedures (SOPs), ICH-GCP guidelines, and applicable Australian regulatory requirements (including TGA). The successful candidate will be a key member of the clinical operations team, interfacing directly with investigational sites.

Responsibilities and Duties

• Perform all aspects of site management through onsite and remote monitoring visits, including site selection, initiation, routine monitoring, and close-out.
• Ensure the protection of study subjects by verifying that informed consent procedures and protocol compliance are followed.
• Conduct source data verification (SDV) to assess the accuracy, completeness, and reliability of clinical data reported in case report forms (CRFs).
• Review the management of investigational product (IP) accountability, storage, and reconciliation at sites.
• Identify, track, and ensure resolution of site issues, protocol deviations, and adverse events.
• Complete monitoring visit reports and follow-up letters in a timely manner.
• Maintain and update trial master file (TMF) documents to ensure audit readiness.
• Develop and maintain strong, collaborative relationships with investigators and site staff.
• Provide ongoing protocol and study process training to site personnel.
• Report on site status, patient recruitment, and data issues to the clinical team.
• Ensure all site activities comply with ICH-GCP, company SOPs, and Australian regulatory standards.

Educational Requirements:

• University degree in Life Sciences, Pharmacy, Nursing, or a related field is required.
• Must have the legal right to work in Australia.

Experience

• Minimum of 2-4 years of independent, on-site monitoring experience as a CRA within a Sponsor or CRO environment, with proven experience in Australia.
• Solid understanding and practical application of ICH-GCP guidelines and Australian clinical trial regulations (TGA).
• Experience in managing site dynamics and building effective site relationships.
• Strong attention to detail, and excellent analytical and problem-solving skills.
• Superior organizational and time management skills with the ability to manage multiple priorities.
• Ability to work both independently and collaboratively within a team.

Other Skills and Abilities

• Proficient in Microsoft Office Suite; experience with EDC and CTMS systems is preferred.

Physical Demands & Travel

• Valid driver’s license and willingness to undertake frequent domestic travel (up to 60-70%) to investigational sites across Australia.