Job Title

Select how often (in days) to receive an alert:Project Manager-Cancer imaging/TheranosticDate: 31 Mar 2025Unit: Nuc Med Support StaffDivision: Chief Operating OfficerDepartment: Cancer Imaging OperationsAt 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 FUTUREFull Time Ongoing RolePeter Mac invites highly motivated individuals to apply for the role of Project Manager Clinical Research Coordinator. This role is responsible for the project management and coordination of a portfolio of clinical research as part of the Department of Cancer Imaging. Research includes both imaging and the growing field of Theranostics. Peter Mac has established itself as a global leader establishing the Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) that has performed landmark phase 1 to phase 3 clinical trials.The Project Manager/Clinical Research Coordinator will ensure that all clinical research studies are managed according to the International Conference for Harmonization (ICH) guidelines for good clinical practice (GCP) and the National Statement on the Ethical conduct of research involving human, thus ensuring the safety and protection of participants and the integrity of research data subsequently collected.You will be responsible for coordinating research activities from inception through to completion, including but not limited to; REDCap database development & management, HREC/RGO submissions, study start up, participant recruitment & coordination, data collection and reporting & quality assurance activities. The role suits driven candidates with previous clinical trials experience who strive for continuous improvement and have the ability to work effectively both independently and within a multidisciplinary team.Inline with the Enterprise Agreement ALLIED HEALTH PROFESSIONALS (VICTORIAN PUBLIC SECTOR) (SINGLE INTEREST EMPLOYERS) ENTERPRISE AGREEMENT 2021-2026, Salary range between $104,135.20 - $110,676.8 based on years of experience.Applicants to this role should provide a covering letter outlining relative key skills and experience to assist us with our assessment.Applications Close: 11:59PM Tuesday 15 April 2025.______________________________________________________________________________________________________Position SummaryThis role is responsible for the project management and coordination of a portfolio of clinical research as part of the Department of Cancer Imaging. Research includes both imaging and the growing field of Theranostics. Peter Mac has established itself as a global leader establishing the Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) that has performed landmark phase 1 to phase 3 clinical trials.The Project Manager-Cancer imaging/Theranostic will ensure that all clinical research studies are managed according to the International Conference for Harmonization (ICH) guidelines for good clinical practice (GCP) and the National Statement on the Ethical conduct of research involving human, thus ensuring the safety and protection of participants and the integrity of research data subsequently collected. These duties are to be performed with the ongoing objective of supporting the Peter Maccallum Cancer Centre strategic plan of achieving continued excellence in service provision by ensuring that evidence-based evaluation is the basis for clinical practice.Allied Health ProfessionalsClassification or Salary RangeGrade 3JB10 - JB13Key RelationshipsInternalResearch ManagerProstate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) Research teamResearch participants & their caregiversSenior Medical staff- Principal and Co InvestigatorsOffice of Cancer ResearchMultidisciplinary team membersCancer Imaging staff i.e. Nuclear Medicine Technologists, Nuclear Medicine Physicians, Administrative staff.Internal stakeholders as relevant to trial/study conduct- i.e. Same Day services, Inpatient wards, Outpatients, Pathology, Pharmacy, Surgery, Radiopharmaceutical Sciences.Health Information, Health Services Research, Biostatistics and Cancer Trials StaffInternal Human Research Ethics Committee (HREC)ExternalClinical trial site staff, Research Nurses, Principal and Associate InvestigatorsClinical Trial Sponsor representatives from pharmaceutical companies and collaborative groupsMedical practitioners at other hospitals and medical centersCancer Trials Australia, Cancer Council of VictoriaStaff at other hospitals, Health Information ServicesExternal laboratories and diagnostic imaging centersProfessional bodies such as Australian Gastrointestinal Trials Group (AGITG), European Neuroendocrine Society (ENETS), Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP)Funding bodies (NHMRC, Victorian Cancer Agency, Prostate Cancer Foundation, Movember)EducationSkillsProven working knowledge of ICH GCP, the current NH&MRC Clinical trial policies and an understanding of the international regulatory and research governance requirementsProficient in using REDCap including design of data capture tools and extraction of dataSound knowledge and demonstrated experience using Microsoft Office software including Word, Excel, Teams and Outlook.Understanding of medical terminology.Excellent written and oral communication skills.Personal confidence and initiative required to deal with people from diverse backgrounds and experiences.Excellent organisational, problem solving and analytical skills.Ability to work without supervision and effectively in a group setting.Ability to engender cooperation and support from colleagues.Commitment to excellence in customer service.Certifications, Licenses & RegistrationsKey Accountabilities1.Clinical Research Set-up and Trial CoordinationAll necessary documents are prepared and submitted to the Human Research Ethics Committee and Research Governance Office (including applications, amendments and annual reports).Support training of delegated trial staff. Ensuring all staff participating in the care of research participants have the appropriate experience and training in accordance with Peter MacCallum mandatory training policy with the Principal Investigator for each trial completing the delegation of authority log for all staff delegated to the trial.Work within and monitor standards of care in the defined research protocols, SOPs and practice guidelines of the Department of Cancer Imaging, hospital policies & procedures. Contributing to the development of policies and procedures within the Department & organisation as necessary.Ensure that studies are undertaken in accordance with the terms approved by the institutional ethics committee, TGA, ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans.Demonstrates through practice, knowledge of ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans.Coordinates participants to ensure compliance with the protocol.Demonstrates knowledge of each designated clinical trial protocol2.Data ManagementObtains data and completes data collection forms in a timely fashion. Ensures that all data collected can be verified to source as per ICH GCP.Maintains integrity of information in case record forms and databases, taking steps to collect the data, checking the consistency and accuracy of data and making appropriate corrections.Maintain the Investigator Site File in compliance with ICH GCP.Demonstrates knowledge of patient/data privacy and confidentiality guidelines and legislation and adheres to these to ensure patient privacy and confidentiality is protected.3.Project ManagementProject management of Investigator Initiated research. Supporting the development of study documents i.e. protocols, imaging manuals, investigator site file templates.Ensuring reporting requirements are met.Completing quality assurance activities evaluating ICH GCP compliance.Identifies factors influencing the successful conduct of the trial or project and takes steps to overcome identified problems.Database development: Timely design, development and testing of databases to meet stakeholder requirements.Troubleshooting and resolution of production database issues.Migration of data across data capture platforms as required. Providing users with advice and technical support on problem rectification and tailored database improvement upon request.Performance of data management tasks throughout the project life cycle, as required. Includes; validation and data quality assurance, data cleaning, manipulation and delivery, archiving and destruction of data.Knowledge of, and compliance with, institutional data policies and procedures including the management of user permissions.Participation in relevant policy and operational procedure development.Key Accountabilities (Contd..)5.Quality Assurance activitiesSupport the development and conduct of clinical audit and quality assurance projects including but not limited to protocol development, data collection and evaluation.6.Communications and TrainingDevelop high-quality, timely communications materials with a focus on the ProsTIC funded research. This may include, but is not limited to: website content, intranet content, email newsletters, flyers, training materials, event materialsSupport the onboarding and training of ProsTIC funded research staff.7.Professional Development and EducationDemonstrates a commitment to personal continuing professional development and participates in performance appraisal and review.In conjunction with educator & manager, identify professional development goals and work towards meeting these within agreed timeframes.Undertakes additional training in order to acquire the knowledge and skills needed to implement new study protocols from a variety of clinical specialtiesMaintains mandatory training requirements as defined by hospital policy.8.To function as an integral member of the Clinical Trials TeamDevelops and participates in appropriate quality activities. Participates in Departmental and Team Meetings.Takes on additional responsibilities in the team, as agreed with the Research Manager/Director Molecular Imaging and Therapeutic Nuclear Medicine.Takes responsibility for ensuring trial participants are seen in primary study coordinator''s absence and that protocol requirements are carried out according to protocol and without incident.9.Provides support to the Research ManagerTakes on additional functions within the team as discussed and decided with the Research Manager______________________________________________________________________________________________________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 is a child safe organisation and has a commitment to child safety and wellbeing.WHY WORK FOR PETER MACPeter 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.The Peter MacCallum Cancer Centre acknowledges the traditional owners of the land on which our five sites are located throughout Victoria. We recognise their strength and resilience and pay our respects to their Elders past and present. #J-18808-Ljbffr