At a Glance
- Tasks: Monitor and manage clinical trial sites, ensuring compliance and data accuracy.
- Company: Join a dynamic team in the clinical research field.
- Benefits: Competitive salary, flexible work options, and professional growth opportunities.
- Other info: Collaborative environment with strong focus on site relationships and training.
- Why this job: Make a real difference in healthcare while developing your career.
- Qualifications: Degree in Life Sciences or related field; 2-4 years CRA experience required.
The predicted salary is between 77355 - 94545 $ per year.
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.
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Senior CRA employer: Sironax
Join our dynamic team as a Senior Clinical Research Associate in Australia, where we prioritise employee growth and development within a supportive work culture. We offer competitive benefits, including flexible working arrangements and opportunities for professional advancement, all while making a meaningful impact on clinical research and patient care. Our collaborative environment fosters strong relationships with site staff and investigators, ensuring that you play a vital role in the success of clinical trials.
