14 May, 2024

Clinical Trial Coordinator - Radiation Oncology

  • Peter MacCallum Cancer Centre
  • Bendigo VIC, Australia
Part time, Fixed term Clinical Research

Job Description

Clinical Trial Coordinator - Radiation Oncology

Date:  13 May 2024
Site:  Bendigo
Company:  Peter MacCallum Cancer Centre
Unit:  Radiation Oncology Research
Division:  Chief Operating Officer
Department:  Radiation Oncology
 

At Peter Mac we aim to continuously improve cancer care, research and education across all cancers and for all people affected by cancer: changing lives, breaking new ground. Everything we do is underpinned by our core values, Excellence, Compassion and Innovation. Welcoming people from a wide variety of different backgrounds and experiences is critical to fostering innovation, cultivating compassion, attracting and retaining top talent and providing the best possible cancer care for our patients.

 

YOUR ROLE IN OUR FUTURE

Join the PMCC Bendigo team for a 7 months contract (commencing 01 July 2024 until 24 January 2025) - 0.4EFT

As an experienced member of the Radiation Oncology research team, the Clinical Trial Coordinator (CTC) will contribute to the delivery of direct and indirect clinical trial related care of patients and associated data collection for clinical trials and research studies undertaken in the Department of Radiation Oncology (DRO). The CTC will ensure clinical trials are conducted in accordance with Good Clinical Practice (ICH E6 GCP), the NHMRC National Statement on Ethical Conduct in Human Research and National Clinical Trials Governance Framework (NCTGF).

Key responsibilities include:

  • Study set up including (but not limited to) ethics & governance submissions, protocol & PICF development, site initiation and PI support

  • Patient screening, identification and registration

  • Clinical research coordination including activities related to trial initiation, HREC reports and amendments, study closure and archiving

  • Data collection, information retrieval, data entry, safety reporting and database management

  • Clinical trial support: familiarity with all DRO studies to enable backup of other staff when necessary

  • Compliance with ICH GCP ensuring the safety and protection of trial participants and the integrity of data subsequently collected

 
KEY ACCOUNTABILITIES

1.  Clinical Research Coordination

  • Ensure that studies are undertaken in accordance with the protocol, HREC approval conditions and ICH-GCP.

  • Ensure effective communication processes are in place to meet the needs of patients, investigators and other members of the multidisciplinary research team.

  • Screen/register only appropriate patients onto clinical trials as per clinical trial protocol inclusion/exclusion criteria. Follow patients as per protocol and be involved with patient withdrawal from clinical trials as appropriate.

  • Coordinate and participate in internal and external clinical monitoring/auditing activities as required to ensure professional standards and improvement, as well as regulatory and scientific requirements are met.

  • Provide ongoing support and information to patients, assist investigators with seeking participant consent for research and be actively involved in the ongoing informed consent process.

  • Knowledge of each clinical trial protocol including procedures and documentation to ensure safe and accurate conduct of the research.

  • Ensure that all protocol data collection requirements are met, biological samples are collected & processed, CRFs are completed consistently and accurately taking steps to collect the data, in a timely manner and filed securely.

  • Ensure notification of serious adverse events and adverse events are reported according to protocol requirements, HREC, ICH GCP and to ensure patient safety.

  • Clinical trial support: familiarity with all DRO studies to enable backup of other staff when necessary.

 

2. Research Development and Support

  • Contribute to the development of research protocols, CRFs, PICFs and other study documents.

  • Coordinate and provide support for study set-up including ethics and governance submissions ensuring approvals are obtained in a timely manner.

  • Provide assistance and support to investigators with submission of clinical trial and ethics progress reports.

  • Identify factors influencing the successful conduct of trials and takes steps to overcome identified problems and ensure recruitment proceed according to schedule.

  • Recognise the importance of resolving complaints in a timely and effective manner and escalate as appropriate. Be aware of any/all complaints made within the unit and act accordingly.

  • Actively participates in and facilities clinical trial quality improvement projects for the department.

  • Collate KPI data and other data as required for Site Director and RT Campus Director – Bendigo.

 

3.  Professional Practise

  • Maintain up to date clinical research skills and knowledge.

  • Develop the role by using evidence-based practice and continuously improving knowledge following training and education guidelines.

  • Conduct clinical research in accordance with TGA ICH GCP and the NHMRC National Statement on Ethical Conduct in Human Research and relevant state/federal privacy laws.

  • Make professional decisions related to allocated clinical trials on a daily basis and seek clarification where necessary.

  • Able to problem solve and make appropriate clinical and professional decisions as required.

  • Provide professional advice relating to the conduct of clinical research to the multidisciplinary team.

  • Maintain high professional standards in work performance.

  • Function as an integral member of the clinical trials team by building professional relationships with clinical research colleagues and investigators.

  • Act as a patient advocate at all times to ensure the patient’s privacy and safety.

 

4.  Education

  • Demonstrate a commitment to continuing professional development, ensuring personal development needs and professional education and research are identified and met.

  • Maintain mandatory training requirements and function within the guidelines defined by hospital policies.

  • Undertake additional relevant training in order to acquire the knowledge and skills needed to implement new study protocols.

  • Participate in annual performance review/appraisal.

 

Fixed term (7 months), 0.4EFT (30.4hrs per fortnight) commencing 01 July 2024


Position Reports to:  Research Manager - Department of Radiation Oncology

 

Essential Requirements

  • At least 1 year clinical research experience with good understanding of ICH-GCP, National Statement and privacy legislation

  • Experience in ethics and governance submissions

  • Demonstrated excellent team working skills with ability to work without supervision and using own initiative

  • Effective oral and written communication skills and interpersonal skills

  • Commitment to excellence in patient care and in building relationships with research staff

  • Highly developed organizational, problem solving and analytical skills

  • Highly computer literate with experience using electronic medical records, clinical trial databases & proficient in MS Office products.

  • Time management skills/ability to prioritise workload

  • High level of attention to detail

  • Understanding of medical and oncology terminology

Desirable Requirements

  • Oncology/radiation oncology clinical trial experience preferred

  • Postgraduate degree

 

 

 

Applicants to this role should provide a covering letter outlining relative key skills and experience to assist us with our assessment. <> 

For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position summary. Alternatively, please contact us using the information below for a confidential discussion.

Hiring Manager: Adrienne See
Contact Number: 03 8559 8316
Email: adrienne.see@petermac.org

Applications Close: 11:59pm, Monday, 20th May 2024
______________________________________________________________________________________________________

Position Summary

As a member of the Radiation Oncology research team, the Clinical Trial Coordinator (CTC) will contribute to the delivery of direct and indirect clinical trial related care of participants and associated data collection for clinical trials and research studies (collectively known as “Study/ies”) undertaken in the Department of Radiation Oncology (DRO). The CTC will ensure studies are conducted in accordance with Good Clinical Practice (ICH E6 GCP), the NHMRC National Statement on Ethical Conduct in Human Research and National Clinical Trials Governance Framework (NCTGF).


Key responsibilities may include (but not limited to):
•    Study set up including regulatory submissions and compliance, study document development, site initiation and Principal Investigator (PI) support
•    Participant identification, consent facilitation, screening and registration
•    Clinical research coordination including activities related to study initiation, regulatory compliance, study closure and archiving
•    Data collection and verification, information retrieval, data entry, safety reporting and database management
•    Clinical trial support: familiarity with all DRO studies to enable backup of other staff when necessary
•    Compliance with ICH-GCP ensuring the safety and protection of study participants and the integrity of data subsequently collected

Enterprise Agreement

Allied Health Professionals (Victorian Public Sector) (Single Interest Employers) Enterprise Agreement 2021 – 2026

 

Classification or Salary Range

1RA4-1RA10

 

Immunisation Risk Category

Immunisation Category B

Key Relationships

Internal

•    Participants and their carers
•    DRO research staff
•    PIs, co-investigators and associated clinical trial doctors
•    Ethics & Governance office (HREC/RGO)
•    Radiation Therapy services staff and Physicists
•    Trial Managers and Statisticians in Centre for Biostatistics and Clinical Trials (BaCT)
•    Health Information Services
•    Chemotherapy day unit, Cancer Imaging, Nuclear Medicine, Pathology, Medical Oncology & Pharmacy Department staff
•    Nursing staff
•    The Office of Cancer Research

External •    Partnering hospitals
•    External research organisations and health professionals to obtain relevant study related data and/or pathology samples
•    Study sponsors, study managers and collaborative groups (such as TROG, ANZUP, BCT, AGITG, NRG Oncology)
•    Liaise with external regulatory bodies as required
•    Industry sponsors and Clinical Research Assistants (CRA) where appropriate

 

Education

 

Skills

Essential Requirements

•    Relevant tertiary health sciences degree
•    At least 1 year of clinical research experience with good understanding of ICH-GCP, National Statement, NCTGF and privacy legislation
•    Experience in ethics and governance submissions
•    Demonstrated excellent team working skills with ability to work without supervision and using own initiative
•    Effective oral and written communication skills and interpersonal skills
•    Commitment to excellence in patient care and in building relationships with research staff
•    Highly developed organisational, problem solving and analytical skills
•    Highly computer literate with experience using electronic medical records, study databases & proficient in Microsoft Office products.
•    Time management skills/ability to prioritise workload
•    High level of attention to detail
•    Understanding of medical and oncology terminology

Desirable Requirements •    Oncology/radiation oncology study experience
•    Postgraduate degree

 

Certifications, Licenses & Registrations

 

Key Accountabilities

Key Accountabilities

Demonstrated by / Key Performance Indicators

1. Clinical Research Coordination •    Ensure that studies are undertaken in accordance with the protocol, regulatory approvals, and ICH-GCP.
•    Ensure effective communication processes are in place to meet the needs of participants, investigators and other members of the multidisciplinary research team.
•    Screen/register only appropriate participants as per study protocol inclusion/ exclusion criteria.  Follow participants as per protocol and be involved with participant withdrawal from study as appropriate.
•    Coordinate and participate in internal and external clinical monitoring/auditing activities as required to ensure professional standards and improvement, as well as regulatory and scientific requirements are met.
•    Provide ongoing support and information to participants, assist investigators with seeking participant consent for research and be actively involved in the ongoing informed consent process.
•    Knowledge of each study protocol including procedures and documentation to ensure safe and accurate conduct of the research.
•    Ensure that all protocol data collection requirements are met, biological samples are collected & processed, Case Report Forms (CRFs) are completed consistently and accurately taking steps to collect the data, in a timely manner and filed securely.
•    Ensure notification of serious adverse events and adverse events are reported according to protocol requirements, HREC/RGO, ICH-GCP and to ensure participant safety.
•    Clinical trial support: familiarity with all DRO studies to enable backup of other staff when necessary.

2. Research Development & Support

•    Contribute to the development of new study protocols and proposals, and study specific documentation including CRFs, Patient Information and Consent Forms (PICFs) and other study aids.  
•    Coordinate and provide support for study set-up including HREC/RGO submissions ensuring approvals are obtained in a timely manner.
•    Provide assistance, expert advice and support to investigators with submission of study, research grant and ethics progress reports.
•    Identify factors influencing the successful conduct of studies and takes steps to overcome identified problems and ensure recruitment proceeds according to schedule.
•    Recognise the importance of resolving complaints in a timely and effective manner and escalate as appropriate.  Be aware of any/all complaints made within the unit and act accordingly.
•    Actively participate in and facilities study quality improvement projects for the department.

Key Accountabilities (Contd..)

Key Accountabilities Demonstrated by / Key Performance Indicators
3. Professional Practice

•    Maintain current clinical research skills and knowledge
•    Develop the role by using evidence-based practice and continuously improving knowledge following training and education guidelines.
•    Conduct clinical research in accordance with Therapeutic Goods Association (TGA), ICH-GCP, NHMRC National Statement on Ethical Conduct in Human Research and other relevant state/federal regulations and privacy laws.
•    Make professional decisions related to allocated studies daily and seek clarification where necessary.
•    Able to problem solve and make appropriate clinical and professional decisions as required.
•    Provide professional advice relating to the conduct of clinical research to the multidisciplinary team.
•    Maintain high professional standards in work performance.
•    Function as an integral member of the clinical trials team by building professional relationships with clinical research colleagues and investigators.
•    Act as a participant advocate at all times to ensure the participant’s privacy and safety are upheld.

4. Education

•    Demonstrate a commitment to continuing professional development, ensuring personal development needs and professional education and research are identified and met.
•    Maintain mandatory training requirements and function within the guidelines defined by hospital policies.
•    Undertake additional relevant training in order to acquire the knowledge and skills needed to implement new study protocols.
•    Participate in annual performance review/appraisal.

 

______________________________________________________________________________________________________

 

For further information about this opportunity, click Apply to be redirected to the Peter Mac Careers page where you can review the position profile. Alternatively, please contact us for a confidential discussion.

 

 

Peter Mac requires its staff to be fully vaccinated against COVID-19. Please contact us if you would like to discuss this requirement.

 

 

WHY WORK FOR PETER MAC

 

  • Peter Mac offer a range of benefits which support our people both personally and professionally.

  • Our staff benefits include award winning facilities, professional development and events, a health and wellbeing program, flexible work practices and policies and financial benefits such as salary packaging.

  • We encourage applications from Aboriginal and Torres Strait Islander people, all members of the LGBTQI community and people with a disability.


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