Clinical Research Associate
2 weeks ago
Role/Function Summary:
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.
How to Apply:
If you meet the above criteria and are excited by the opportunity to join our team, please submit your application directly.
Please note:
We are not accepting applications or outreach from recruitment agencies for this role. All candidates must apply directly.
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