Clinical Project Manager

Full time and Maximum Term

  • Exciting role within Australia’s premiere site for clinical trials
  • Generous salary packaging benefits
  • Full time – onsite role

About the position

The Clinical Project Manager will facilitate the implementation, conduct, completion and reporting of clinical studies sponsored by the ONJCRI. This includes trial monitoring, ongoing trial administrative support, and maintaining positive and transparent relationships with key stakeholders including sponsors, contract research organisations, clinicians and government/regulatory bodies.

Key accountabilities include:

  • Ongoing monitoring and support of the Institute’s clinical studies, including:
    • Site implementation of Protocols, Informed Consent forms and Investigator Brochures, Case Report Forms.
    • Human research ethics and governance submissions for applicable studies (including laboratory based studies).
    • Monitoring of trial-related duties and responsibilities to trial-related staff.
    • Study registration, site initiation, monitoring and management.
    • Establish and maintain Trial Master File and Investigator Site File.
    • Data handling, record keeping, retrieval and clarification, and archiving.
    • Investigator meeting preparation/participation.
    • Safety reporting process for study sites.
    • Study status tracking, study file maintenance and archiving.
  • Conduct/attend monitoring visits, including site initiation and close-out visits, as required.
  • Contribute to the development of trial specific monitoring procedures and standards and ensure consistent implementation.
  • 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.

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:

  • Prior experience in time/project/budget/management.
  • 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.
  • Expert 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 guridelines.
  • Expert knowledge of national ethics submission systems and essential documents.
  • Ability to perform ICH-GCP and other regulatory compliant monitoring of clinical studies.
  • Ability to multitask and work independently.
  • Excellent verbal and written communication skills
  • 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 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-090/2022 to Dr. Jodie Palmer, Senior Manager Clinical Operations, via email at jobs@onjcri.org.au

Closing date for applications: 21 October 2022