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Breast Cancer Research Centre - WA
Nedlands, Western Australia
19 days ago
Breast Cancer Research Centre - WA
Nedlands, Western Australia
19 days ago

Description

Permanent Part-time 0.2FTE

To support the Director of BCTU in the conduct of pharmaceutical-sponsored clinical trials undertaken at BCRC-WA and the oversight of the clinical trials research team. 

Breast Clinical Trials Unit (BCTU)

BCRC-WA is an independent not-for-profit research group based at the Hollywood Private Hospital in Perth, Western Australia. It aims to conduct research into the causes, prevention and treatment of breast cancer and to enhance multidisciplinary care to individuals with breast cancer by providing greater support and improving quality of life.

BCRC-WA mission is to offer the best treatment, undertake high-quality research, deliver broad-based education, and provide additional support to individuals with breast cancer and their families.

BCRC-WA vision is to improve the outcome and minimise the impact of breast cancer through excellence in treatment, research and education.

BCTU is the clinical research component of BCRC-WA and undertakes clinical trials for breast cancer patients.  Women and men with breast cancer are able to access cutting edge treatment through participation in clinical trials subject to their suitability.



Requirements

Requirements

  • Bachelor of Medicine, Bachelor of Surgery or equivalent MD
  • FRACP Medical Oncology or equivalent
  • Current registration with AHPRA

Essential Selection Criteria

  • Previous pharmaceutical clinical trials research experience as reflected by patients recruited, and role as principal or co-investigator
  • Demonstrated knowledge of ICH-GCP guidelines with current certificate
  • Research publication experience – in particular where you were an author in pharmaceutical trials that you recruited patients to (e.g. abstract, poster or peer reviewed manuscript)
  • Demonstrated interpersonal and leadership skills in any area of medical oncology, including motivating and mentoring teams with an understanding of human resource management
  • Demonstrated high level written and verbal communication skills with well-developed cross-cultural sensitivity and diplomacy
  • Proven ability to organise heavy workloads, including the ability to prioritise and delegate
  • Demonstrated problem solving skills with capacity to learn and apply principles of budget management
  • Demonstrated commitment to applying relevant and applicable policies, procedures and legislation in the day-to-day performance of the functions of this position
  • Proficiency with utilising computer software

  Desirable Selection Criteria

  •  Recognises fundamental importance of evidence-based medicine
  • Actively input into study protocol design at first time of contact from pharmaceutical company for study participation, with attention to non-standard of care procedures and suggestions for modifications to the protocol, if appropriate
  • Prior experience with design and utilisation of database software, ideally Filemaker Pro
  • Prior experience as advisor for Pharmaceutical advisory boards (nationally or internationally)
  • Prior experience with negotiating trial contract during feasibility or initiation of a pharmaceutical trial

Accountabilities and Responsibilities

 Research Activities

  • Selection of scientifically and clinically relevant projects
  • Review potential new pharmaceutical trials and complete trial feasibility, taking into account patient recruitment by other PBCI Medical Oncologists
  • Play an active role in developing PBCI data collecting system to enable adequate feasibility assessment for new pharmaceutical trials
  • Attend Site Evaluation Visits for new trials
  • Respond to clinical queries from Registered Nurses and Unit Manager in a timely fashion
  • Signing of study documents and digital platforms in line with study requirements and timelines
  • Review safety notifications as required
  • Review study protocols, amendments, SUSARs, newsletters, patient informed consent
  • Oversee SAE reporting for recruited patients by members of PBCI
  • Facilitate other PBCI clinicians in their recruitment of patients to trials, where appropriate to that clinician
  • Attend weekly Multidisciplinary Team meetings

Communication

  • Meet with study monitors
  • Review monitoring visit reports and identify issues that relate to Sponsor or CRO delegate, as compared to BCTU staff, to enable accurate resolution
  • Be available to meet with medical monitors
  • Regular meetings with the BCRC-WA Trials Unit (BCTU) team
  • Regular meetings with the Unit Manager and/or QA team
  • Responsible for interim and final reports of trials conducted to BCRC-WA Board of Directors

 Professional Development/Team Development

  • Provide professional development for trials staff
  • Overview of SOPs for the department
  • Promote the type and extent of pharmaceutical trial conducted by BCRC-WA to the community and other health institutions (in way of writing articles, doing interviews with media or community groups)
  • Promote teamwork and provide internal education to all staff in BCTU
  • Maintain professional network with service providers and other medical professional services
  • Develop strategies for maintaining unit’s efficiency and staff retention
  • Ensure quality of BCTU is upheld

Job Information

  • Job ID: 59021185
  • Location:
    Nedlands, Western Australia
  • Position Title: Clinical Lead - Pharmaceutical Trials
  • Company Name: Breast Cancer Research Centre - WA
  • Job Function: Medical Oncology
  • Job Type: Part-time
  • Job Duration: Indefinite
  • Min Experience: 3-5 Years
  • Required Travel: None

Please refer to the company's website or job descriptions to learn more about them.

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