Clinical Research Associate
2 weeks ago
About our business
Accelagen is a leading, full-service Pharmaceutical and Medical Device Development Organisation.
The Accelagen team is comprised of clinical specialists who provide wide ranging services and support in the development and implementation of clinical trials, for both local and international clients.
The organization is experiencing robust growth, while exhibiting a standard of professionalism and dedication that exceeds our clients' expectations. We are looking for CRAs to compliment these services.
About the role
Reporting to the Head of Clinical Operations, as part of a study team, you will contribute to all aspects of Site Management in this innovative and hands-on role. Key responsibilities of the role include but are not limited to:
Site selection, initiation, monitoring, and close-out visits on various projects.
Administer protocol and related training to assigned sites and establish regular lines of communication.
Evaluate the quality and integrity of study site practices related to the proper conduct of the study protocol and adherence to regulations.
Study management by preparing and tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans.
Site feasibility activities.
Negotiate study budgets with potential investigational sites.
**Subject safety management**: Management of SAE process.
About You
To be successful in the role you will have a minimum of 1-2 years’ experience in clinical trial site management as a CRA, with a demonstrated sufficient understanding of the clinical trial environment (GCP) and an understanding of the clinical trial life cycle. You will be tertiary qualified within life sciences, pharmacy, RN or another related technical qualification. You have strong attention to detail and enjoy problem solving, with a high level of written and verbal communication. You are able to travel interstate across Australia to attend study site visits.
This position is onshore in Australia, and is home or Melbourne office based.
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