Clinical Trials Coordinator

6 days ago

Melbourne, Victoria, Australia beBeeClinical Full time $90,000 - $130,000

Job Description:

\
  • \
  • The Clinical Research Associate I will be responsible for conducting routine monitoring and closeout of clinical sites, maintaining study files, conducting pre-study and initiation visits, liaising with vendors, and performing other assigned duties.\
  • They will manage all aspects of site management as prescribed in project plans, ensuring compliance with regulatory requirements and guidelines.\\/ul>

Responsibilities:

\
  1. \
  2. Verify that study staff conducting the protocol have received necessary materials and instructions for safely entering patients into the study.\
  3. Ensure the protection of study patients by verifying adherence to informed consent procedures and protocol requirements according to applicable regulatory requirements.\
  4. Review data submitted on Case Report Forms (CRFs) or other data collection tools to ensure accuracy and integrity.\
  5. Monitor data for missing or implausible entries.\
  6. Ensure efficient use of Sponsor and Covance resources by performing required monitoring tasks according to SOPs and established guidelines.\
  7. Prepare accurate and timely trip reports.\
  8. Interact with internal work groups to evaluate needs, resources, and timelines.\
  9. Act as contact for clinical trial supplies and other suppliers as assigned.\\/ol>

Additional Responsibilities:

\
  • \
  • Assist Senior CRA with managing investigator site budgets.\
  • Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs.\
  • Independently perform CRF review, query generation, and resolution against established data review guidelines on Covance or client data management systems as assigned by management.\
  • Assist with training, mentoring, and development of new employees.\
  • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.\\/ul>

Requirements:

\
  • \
  • Six (6) months experience in a related role (e.g., site management, in-house CRA, study coordinator, research nurse, etc.).\
  • Basic understanding of Regulatory Guidelines.\
  • Ability to work within a project team.\
  • Good planning, organization, and problem-solving skills.\
  • Good computer skills with a working knowledge of a range of computer packages.\
  • Valid Driver's License.\\/ul>

Education:

\
  • \
  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure).\
  • Basic knowledge of Regulatory Guidelines.\
  • Basic understanding of the clinical trial process.\
  • Fluent in local office language and in English, both written and verbal.\\/ul>

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