At a Glance
- Tasks: Support clinical teams and manage study documentation for exciting projects.
- Company: Join a leading clinical research organisation with a focus on innovation.
- Benefits: Competitive salary, flexible work options, and opportunities for professional growth.
- Other info: Great career advancement opportunities in a supportive team culture.
- Why this job: Make a real difference in healthcare while developing your skills in a dynamic environment.
- Qualifications: Experience in Life Sciences or related fields; previous CRA experience is a plus.
The predicted salary is between 63000 - 77000 $ per year.
Inhouse Clinical Research Associate - Australia
The Inhouse Clinical Research Associate (IHCRA) provides in-house support to the clinical team according to project requirements, ICH GCP guidelines, local or global regulatory requirements and Novotech or Client SOPs.
Responsibilities
- Support the clinical team's inhouse activities on assigned projects.
- Co-ordinate and maintain clinical study documentation in the Trial Master Files (TMF) including the tracking of documents, preparation for internal/external audits, conducting routine QC reviews and final reconciliation, according to the requirements of ICH GCP and Novotech (or client) SOPs.
- Support the clinical team in essential document development, collection and management process including any translations according to Good Documentation Practice, ICH GCP and Novotech (or client) SOPs.
- Manage the Clinical Trial Management System (CTMS), ensuring site compliance scores are maintained to a high level and entered in accordance with company requirements.
Follow up with relevant team to update and maintain site milestones, subject tracking and PISCF's, ensuring accuracy and completeness of the data.
- Create the Investigator Site Files, co-ordinating the ordering, dispatch and tracking of trial materials (e. g., patient cards and diaries, lab supplies, drug supplies, etc.) according to the logistical requirements of the study.
Ensure safe and orderly storage of study materials at Novotech and maintain stock reports as requested by the PM/CRA.
- May assist the CRAs with the preparation of onsite or remote monitoring visits and follow-up action items from previous monitoring visits.
- May assist IRB submission (safety reporting: other site SUSAR, Line listing, DSUR, including site communication, CSR submission etc.) including tracker management during project maintenance and close out phase.
- Minimum Qualifications & Experience
- Relevant experience/qualifications in Life Sciences or related field or administration would be preferable.
Experience working in the pharmaceutical, CRO or healthcare industry is advantageous.
- A minimum of 1 years experience as inhouse CRA or relevant clinical administration roles.
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Inhouse Clinical Research Associate – Australia in Brisbane employer: Novotech
Novotech is an exceptional employer that fosters a dynamic and collaborative work culture, perfect for those passionate about advancing their careers in toxicology and regulatory affairs. Located in Australia, we offer our employees comprehensive growth opportunities, competitive benefits, and the chance to work alongside industry experts on cutting-edge projects in clinical trials. Join us to make a meaningful impact in the field while enjoying a supportive environment that values innovation and professional development.
