Clinical Trial Coordinator-1

Job Description:

• Permanent Full Time position

• Excellent benefits including salary packaging

• Challenging and rewarding work environment

• Ongoing training and development opportunities

• 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

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

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

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

Classifications for this position will range from JA7-JB1 ($90,235.60 - $103,724.40 per annum)

Your Contribution

• 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

What we Offer

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

• Salary Packaging – Increase your take home pay!

• Culture of continuous improvement

The Haematology Clinical Research Centre
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.

Working at St Vincent’s
St Vincent’s 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).
Please contact us if you would like to know more.

Contact

Anupa Dey [email protected]

LOCAL WORK ENVIRONMENT
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.

4. POSITION PURPOSE
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.

5. POSITION 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

6. INCUMBENT OBLIGATIONS
General
 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 as
appropriate.
 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

INCUMBENT 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

8. SELECTION CRITERIA
8.1 ESSENTIAL REGISTRATION, LICENSE OR QUALIFICATION REQUIREMENTS
 Completion of either a Bachelor of Pharmaceutical Science, Biomedical Science or Applied
Science, 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, and
negotiation 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 deadline

Closing Date:

Reconciliation Action Plan:

At St Vincent's 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://www.svha.org.au/about-us/reconciliation or get in contact at [email protected]

View Reconciliation Action Plan

Code of Conduct:

View Code of Conduct