(Senior) CRA

Sironax; Australia; Sur place; AUD 90 000 - 110 000; Plein temps

Résumé du poste

Sironax is seeking a proactive Clinical Research Associate (CRA) to join our team in Australia, overseeing on-site monitoring of trial sites and ensuring compliance with ICH-GCP and Australian regulations. You will coordinate monitoring visits, SDV, IP accountability, TMF updates, and training site staff, working closely with investigators to support patient safety and data integrity.

The role requires 2–4 years of on-site CRA experience in a Sponsor or CRO, strong communication and analytical

Qualifications

• On-site CRA with 2–4 years of independent monitoring experience in Australia or equivalent environment.
• Strong knowledge of ICH-GCP and Australian clinical trial regulations (TGA).
• Ability to manage site dynamics and build relationships with investigators and staff.
• Excellent attention to detail and time management skills.

Responsabilités

• Perform site management and on-site/remote monitoring visits, including site selection, initiation, routine monitoring and close-out.
• Verify informed consent, protocol compliance and SDV to ensure data accuracy.
• Review IP accountability, storage and reconciliation at sites.
• Identify and resolve site issues, deviations and adverse events.
• Prepare monitoring visit reports, TMF updates and communication with the clinical team.
• Train site personnel on protocols and processes; report site status and data issues.

Connaissances

Attention to detail

Organizational skills

Analytical thinking

Time management

Teamwork

Independent work

Formation

University degree in Life Sciences, Pharmacy, Nursing or related field

Outils

MS Office Suite

EDC

CTMS

Description du poste

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