Haematology Ethics Coordinator

Job Description:

Become part of the continued growth of the Haematology Clinical Research Centre

Full time Fixed term position until July 2026
Excellent opportunities for career enhancement
Friendly and supportive team environment

About the Role

The Haematology Clinical Trial Coordinator under the guidance of the Unit Manager Clinical Haematologist and Tumor Stream Leads will manage commercial sponsored and investigator driven International early phase clinical trials for haematology patients.

• Full responsibility for the coordination and management of a number of International clinical trials Including (First in Human ( FIH) Phase 1 A&B and Phase 2 A&B complex pharmaceutical sponsored clinical trials

• Coordination and adherence to clinical trial protocols

• Preparation of trial data for onsite or remote monitoring visits including data query resolution

Classifications for this position will range from classification range HIM Grade 2 JA7 - JB1 ($90235.60 - $103724.40 per annum).

Your Contribution

• Completion of either a Bachelor of Pharmaceutical Science Biomedical Science or Applied Science qualifications or other relevant allied health field qualifications..

• Experience in trial coordination (minimum 2 years work experience)

• Experience in complex International Haematological Clinical Trials including Phase 1A & 1B/2A & 2B trials.

• Current Nationally coordinated criminal history check or willing to obtain

What we Offer

• A focus on wellbeing initiatives with regular events and programs

• Confidential solutions-focused employee counselling

• A healthy work/life balance encouraged. Full time employment comes with a monthly Accrued Day Off (additional day off per month!)

• Ability to join Fitness Passport - Your pass to an extensive choice of fitness facilities

• Salary Packaging Increase your take home pay!

• In the heart of Fitzroy CBD at our doorstep close to some of Melbournes best cafes public transport and lots of carparks

• Discounts and Promotions always available through our Foundation

• Regular opportunities for professional development to assist you to reach your career goals

• Culture of continuous improvement

About Haematology Trials Department

The Haematology Clinical Research Centre (HCRC)provides coordination and care to haematology patients who are on clinical trials. Clinical treatment is delivered in the outpatient Cancer Centre Chemotherapy Day Unit and also on the 6th floor of the Inpatient Services Building.

Working at St Vincents

St Vincents Hospital Melbourne (SVHM) is a leading teaching research and tertiary health service. SVHM provides a diverse range of adult clinical services and is driven by values of Compassion Justice Integrity and Excellence.

Application

Please attach your resume and cover letter to your application.

Shortlisting for this position will commence immediately. We encourage you to apply promptly as the advertisement may close early should a suitable applicant be sourced.
We encourage applications from people of all backgrounds and abilities. Inclusion is essential to our mission and diversity reflects the community we serve.
Please visit our website for further information regarding our Aboriginal and Torres Strait Islander Employment at SVHM.
SVHA has a duty of care under work health and safety legislation to eliminate and/or control the risk of transmission of vaccine preventable diseases in healthcare settings. You may therefore be required to undergo mandatory immunisations/vaccinations (including flu vaccinations).

Contact

Anupa Dey

The Haematology Clinical Research Centre provides coordination and care to haematology patients who are on clinical trials. Clinical treatment is delivered in the outpatient Cancer Centre Chemotherapy Day Unit and also on the 6th floor of the Inpatient Services Building.

The Haematology Clinical Trial Coordinator under the guidance of the Unit Manager Clinical Haematologist and Tumor Stream Leads will manage commercial sponsored and investigator driven International early phase clinical trials for haematology patients.

DUTIES

• Full responsibility for the coordination and management of a number of International clinical trials Including (First in Human ( FIH) Phase 1 A&B and Phase 2 A&B complex pharmaceutical sponsored clinical trials

• Coordination and adherence to clinical trial protocols

• Preparation of trial data for onsite or remote monitoring visits including data query resolution

• Preparation of clinical trials in readiness for external and internal on site and remote audits

• Preparation of clinical trials in readiness for government accreditation vists.

• Conduct root cause analysis all monitoring vists/ audit findings and impelemnt corrective actions in consultation with pharmaceutical sponsors.

• Adherence to ALCOA principles with regard to source data collection

• Ensure all trials are conducted as per Good Clinical Practice (GCP) guidelines

• Reporting of all Adverse Events as per protocol mandated timelines and in accordance with (GCP).

• Reporting to HREC all non-serious breaches as per NHMRC guidelines and local ethics committee requirements

• Serious adverse event to be communicated to relevant parties in accordance with Good Clinical Practice (GCP).

• Accurate and timely data management and sponsor data base query resolution

• Develop required paperwork e.g. consent forms trial schemas patient information

• Communicate and liaison with multidisciplinary team including patients regarding the status of the trial and treatment plan

• MRO source data collection and documentation

• Liaise with sponsors / collaborative groups for all relevant aspects of patient care

• Assist with submission of new studies to ethics committees

OBLIGATIONS

• Perform duties of the position to best of their ability and to a standard acceptable to SVHM

• Comply with all SVHM policies procedures by laws and directions

• Treat others with respect and always behave professionally and in accordance with the SVHM Code of Conduct

• Only access confidential information held by SVHM when this is necessary for business purposes maintaining the confidentiality of that information once accessed

• Participate in the annual SVHM performance review process

• Display adaptability and flexibility to meet the changing operational needs of the business

• Comply with applicable Enterprise Bargaining Agreement provisions

• Display a willingness to develop self and seek to improve performance

• Clinical Quality and Safety

• Attend clinical orientation upon commencement

• Maintain clinical registration and any required indemnity cover

• Always work within approved scope of practice under supervision by more senior clinical staff asappropriate.

• Take personal responsibility for the quality and safety of work undertaken

• Take all necessary care and precautions when undertaking clinical procedures

• Complete annual clinical competencies

• Maintain skills and knowledge necessary to safely and skilfully undertake clinical work

• Consult with peers and other experts and refer to other healthcare workers when appropriate and in a timely manner

• Collaborate and clearly communicate with patients/clients and the healthcare team

• Participate in clinical risk management and continuous quality improvement activities as part of day-to-day work

• Person Centred Care

• Ensure consumers receive information in an appropriate and accessible format

• Actively support consumers to make informed decisions about their treatment and ongoing care

• Ensure consumers are aware of their rights responsibilities and how to provide feedback

• Health and Safety

• Protect the health and safety of self and others complying with all health and safety related policies procedures and directions

• Complete required Fire and Emergency Training annually

• Complete required Workplace Culture and Equity Training annually

• Attend general hospital orientation within 3 months of commencement

• As required comply with fit-testing and PPE requirements

CAPABILIITY REQUIREMENTS (Level 2)

The incumbent of this position will be expected to possess the following core capabilities:

• Capability

• Demonstrated behaviour

• Personal

• Personal effectiveness

• Takes responsibility for accurate timely work results

• Learning Agility

• Identifies personal development needs and seeks information from a range of sources

• Outcomes

• Patient/Resident/client centred

• Strives to meet and exceed expectations demonstrating sound judgement

• Innovation and Improvement

• Contributes to improvement by reviewing strengths and weaknesses of current processes

• Strategy

• Driving Results

• Manages own work load to deliver results

• Organisational Acumen

• Understands the interdependencies between units/departments

• People

• Working with and Managing others

• Takes responsibility for ensuring productive efficient teamwork

• Collaboration

• Works collaboratively within and outside the team

CRITERIA
8.1 ESSENTIAL REGISTRATION LICENSE OR QUALIFICATION REQUIREMENTS

• Completion of either a Bachelor of Pharmaceutical Science Biomedical Science or AppliedScience qualifications or other relevant allied health field qualifications.

• Minimum honours degree os post graduate studies in relevant science/ allied health field or relevant industry experience.

• Experience in trial coordination (minium 2 years work experience)

• Experience in complex International Haematological Clincial Trials including Phase 1A & 1B/2A & 2B trials.

• Expert knowedledge in Haeamtological malignancies

• Demonstated competencies in the coordination of International Phase 1-2 Clinical Trials

• Ability to mentor junior team members

• Experience and responsible for the audit preparation for trials

• Knowledge of multiple clinical trial data bases including Medidata RAVE Inform

• Completion of Good Clinical Practice training

8.2 OTHER NON ESSENTIAL REQUIREMENTS

• Highly developed anaylical skills interpersonal skills incorporating excellent communication andnegotiation skills

• Excellent written and verbal communication skills

• High level organisational skills and be able to prioritize

• Computer literate familiarity with Microsoft Office (including MS work excel access

• Power point and outlook)

• Ability and experience in facilitating clinical research activities

• Attention to detail and ability to adhere to documentation guidelines

• Ability to work independently or in a team environment

• Ability to prioritise workload to meet deadlines

Closing Date:

Reconciliation Action Plan:

At St Vincents we acknowledge the importance of creating a work environment that is welcoming safe equitable and inclusive for Aboriginal and/or Torres Strait Islander Employees. As part of our Commitment to Reconciliation and Closing the Gap in employment related outcomes we encourage applications from Aboriginal and Torres Strait Islander Peoples.

For further information visit https:// or get in contact at

View Reconciliation Action Plan

Code of Conduct:

View Code of Conduct