Clinical Trial Data Manager/Monitor

Full time and Maximum Term

About the position

The Clinical Trial Data Manager/Monitor will provide key support to all clinical research projects undertaken by the Institute. The main responsibility will be directly supporting investigators and the Clinical Trials Team in all aspects of conduct and implementation of the clinical trial. This includes ensuring milestones are achieved allowing the engagement of future clinical trials. In addition, the Clinical Trial Data Manager/Monitor will be responsible for the data management and monitoring of patients recruited to the various trials and coordination of the data with participating study sites.

Key accountabilities include:

  • Data management and maintenance of clinical
  • Ongoing monitoring and support of the Institute’s clinical studies, including:
    • Site implementation of Protocols, Informed Consent forms and Investigator Brochures, Case Report
    • Monitoring of trial-related duties and responsibilities to trial-related
    • Data handling, record keeping, retrieval and clarification, and
    • Investigator meeting preparation/participation.
    • Safety reporting process for study
    • Study status tracking, study file maintenance and
  • Conduct/attend monitoring visits, including site initiation and close-out visits, as
  • Contribute to the development of trial specific monitoring procedures and standards and ensure consistent
  • Contribute to the preparation, review, updating and training of Standard Operating Procedures (SOPs).
  • Contribute to the preparation and review of all applicable ethics and regulatory documents, and manuals.
  • Undertake data analysis and data cleaning to ensure clinical and pathological data
  • Provide support in the establishment of clinical and laboratory
  • Assist researchers to utilise data for research

About you

Tertiary qualified (preferably in Biomedical, Health Sciences, RN or equivalent) you will have an outstanding ability to multitask with exceptional organisational and time management skills.  Your excellent interpersonal, verbal and written communication skills ensure that all key stakeholder requirements are met and you will contribute significantly to the successful completion of the clinical studies in a timely manner.

In addition, you will have:

  • Solid understanding of clinical studies, including protocol development, monitoring, site management and data management.
  • Experience in oncology and/or nuclear medicine studies.
  • Experience with Remote Data Capture systems, preferably REDCap, Medidata RAVE or equivalent.
  • Demonstrated competency with database
  • Solid knowledge of Good Clinical Practice (GCP) guidelines provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and applicable regulatory requirements under the Therapeutic Goods Administration (TGA) and Australian
  • Ability to perform ICH-GCP and other regulatory compliant monitoring of clinical
  • Ability to multitask and work independently.
  • Excellent verbal and written communication
  • Proficient level of computer literacy in MS Office environment, particularly Excel.

The Institute is committed to creating a diverse and inclusive work environment and workforce and we strongly encourage people from all backgrounds to apply.

We offer workplace benefits including a hybrid, flexible working model, generous salary packaging benefits to $18,550 per FBT year and 4 extra Institute Days off each year.

To apply:

Please forward your cover letter and CV with 3 referee details (references of the preferred will only be contacted after interview), quoting the reference number ONJCRI-082/2022 to Dr. Jodie Palmer, Senior Manager Clinical Operations, via email at jobs@onjcri.org.au

Closing date for applications: 8 July 2022