Position Purpose (What Is the Primary Objective for This Role? 2-3 Sentences Maximum)

Position Description

Position Title: Pharmacist Grade 2, Clinical Trials Senior Pharmacist, Pharmacy Clinical Trials Manager/ Director of Reports to: Pharmacy Victorian Public Health Sector (Medical Scientists, Pharmacists and Award / Agreement / Contract: Psychologists) Enterprise Agreement 2012 - 2016 Position Type: Pharmacist Grade 2 eg. RN Div 1, Occupational Therapist Gr1, etc. Hours per week: 38 Employment Status: e.g. permanent, fixed term, maternity leave cover, etc. Reports: EFT: Direct Reports: NIL Financial Management: Budget:

Position Purpose (what is the primary objective for this role? 2-3 sentences maximum)

This position is to support Pharmacy Clinical Trials Manager in the provision of pharmacy Investigational Drug Service across Austin Health. Duties and responsibilities include: coordinating, collaborating and providing support of investigational drug service; providing accurate and timely dispensing of trial and trial related drugs; performing administrative responsibilities; providing direct supervision to technician and students; performing education and counselling to participants and their carers, medical and nursing staff and other pharmacists; supporting the Oncology/ Cytotoxic compounding Pharmacist; performing other duties consistent with the job classification, as required.

Key customers are: Director of Pharmacy, Pharmacy Clinical Trials Manager and Clinical Trial staff, trial co-ordinators, pharmaceutical company trial monitors, trial investigators, pharmacy staff, patients and nursing staff.

About Austin Health Austin Health is one of Victoria’s largest health care providers. Comprising the Austin Hospital, Heidelberg Repatriation Hospital and Royal Talbot Rehabilitation Centre, Austin Health is a major teaching and research centre with numerous university and research institute affiliations.

Austin Health employs in excess of 8,000 staff across its three sites; including over 1,000 Doctors and 3,000 nurses, and delivers a full range of leading edge clinical services, including several state-wide services (liver transplant, spinal cord injury service, respiratory support service, child inpatient mental health service). In total, Austin Health provides over 900 beds, including mental health, aged care and rehabilitation beds. The current annual operating budget is $800 million.

Austin Health delivers vital state-wide services to Victorians, including diverse multicultural and veteran communities. It provides community and specialty services to the people of Melbourne’s north-eastern corridor in a safety-focused, team-oriented and stimulating work environment.

Austin Health’s vision is to change healthcare for the better through world class research, education and exceptional patient care. As part of bringing our vision to life, the organisation has recently undertaken an extensive brand refresh and reviewed our organisational model to ensure we are best positioned to deliver contemporary, innovative and patient focussed care.

Position Description Template Revised: June 2016 Page 1 of 7 Austin Health is an equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve. Austin Health is committed to providing an inclusive culture where all employees can contribute to the best of their ability.

Local Work Environment (describe the local work environment eg. role of the department)

The Pharmacy Department Mission Statement is: “Working together to provide optimum pharmaceutical care”.

Comprehensive pharmacy services are provided at the two main sites of Austin and Repatriation campuses and also to Royal Talbot Rehabilitation Centre. Pharmacy staff participate in a co-ordinated work team via a roster system, and they work at different sites (as needed) in order to provide an integrated, high quality service to all pharmacy department customers.

Our philosophy is to foster a learning environment and to promote teamwork as the best method to deliver day to day services, for both our customers and the individual staff members. A priority for all pharmacy staff members must be to use every available opportunity to demonstrate the value of the pharmacy services to our customers. This is a conscious effort to develop and effectively market the pharmacy services, and to target the services offered by achieving a better understanding of the needs of each customer group.

Position Accountabilities (list the main duties & accountabilities of the role) Role Specific  Abide by Austin Health corporate policies and practices as varied from time to time.  Participate in Austin Health Staff Performance and Review Development Program at least once a year.  Undertake not to reveal to any person or entity any confidential information relating to patients and employees, policies, processes and dealings and not to make public statements relating to the affairs of Austin Health without prior authority of the Chief Executive Officer.  Participate in the emergency incident response activities, as defined within the Emergency Response Manual, as and when required, at the direction of management.

The following activities are components of the position to assist in meeting the key responsibilities

Key responsibilities are:

Pharmacy Clinical Trial Duties  Be familiarised with the standard practice involved in conducting a clinical trial, including the policy and procedures, restrictions, adherence to privacy and confidentiality and adverse event reporting procedures. To conduct clinical trials in accordance with the study protocol, legal and hospital requirement, Notes for guidance on Good Clinical Practice, NHMRC National Statement on Ethical Conduct in Research Involving Humans and SHPA standards of Practice of Pharmacy Investigation Drugs Service.  To dispense clinical trials drugs and other medicines related to the trial in a timely manner.  To receive and store investigational drugs as specified in the protocol.  To assist in the maintenance of Clinical Trials Manual.  To assist investigators and sponsors in the development of clinical trial protocols.  To communicate and educate pharmacy staff on relevant clinical trial information.  To counsel participants and their carers and educate medical and nursing staff and other pharmacists.  To report adverse event in accordance with the protocol and Austin Health policy and procedures.

Outcome Measure:  Up-to-date and in-depth knowledge of current practice in Clinical Trials.  Competent in all aspects of clinical trials activities.  Investigational drugs and related medicines dispensed timely in accordance with the protocol.  Dispensing records completed at the time of dispensing.  The handling of clinical trials medications is in accordance with protocol, Therapeutic Goods Administration, Notes for guidance on Good Clinical Practice (AMPH/ICH/135/95)- Annotated with TGA comments and NHMRC National Statement on Ethical Conduct in Research Involving Humans and SHPA standards of Practice of Pharmacy Investigation Drugs Service.  Clinical Trials Manual is current.  Adequate inventory levels are maintained.  Adverse event reported.

Trial Folder Set-up  To set up pharmacy folder for investigational drug for the clinical trial allocated by the Clinical Trials Manager in accordance with investigator’s protocol and comply with relevant legislative Acts, standards and guidelines.

Outcome Measure:  Investigational medicine Pharmacy Folders set up within the requested time frame.

Stock Control and Storage  The Pharmacy Clinical Trials Pharmacist is involved in receiving, returning and sending trial drugs; there are strict procedures for acknowledgement and receipt of trial stock. Many trial drugs also require special handling and electronic temperature logging, both during transit and storage life in the pharmacy.  To ensure investigational drugs are stored separately from other pharmacy stock.  To assist with temperature monitoring of investigational drugs.  To monitor expiry date of investigational drugs.

Outcome Measure:  Investigational drugs are received, stored, returned and disposed in accordance with the protocol.  Investigational drugs stored in the clinical trials area of the pharmacy department.  Investigational drugs are in-date and stored at the correct temperatures and environmental conditions as specified in the protocol, investigator’s brochure or approved information and according to the appropriate statutory regulations.  Storage of investigational drugs complied with the conditions specified by the protocol, clinical trial sponsor or manufacturer, and complied with legislation.  Investigational drugs for each protocol are clearly segregated and be placed in separate containers or areas and clearly labelled with the Protocol Number and/or Human Research Ethics Committee (HREC) number.

Manufacturing  To assist the manufacturing pharmacists in the preparation of trial products including sterile, non-sterile and cytotoxic in accordance with Austin Health guidelines and Standard Operating Procedures.  To prepare Genetically Modified Organisms (GMO) trial products as required.

Outcome Measures:  Successful completion of validation for manufacturing of sterile and cytotoxic products and revalidation every 12 months  Manufactured products prepared when required according to Standard Operating Procedures

Training  To assist Clinical Trials Manager in the orientation and training of pharmacists, resident pharmacists, intern pharmacists, students and technicians rotated to the area.

Outcome Measures:  Clinical trials staff is competent in dispensing trials medicines.  New pharmacy clinical trials staff is familiarised with Clinical Trials Policy and Procedures.

Position Description Template Revised: June 2016 Page 3 of 7 Administrative Duties  To maintain familiarity with all administrative duties in the Clinical Trials area and to assist the Pharmacy Clinical Trials Manager with administrative duties as requested.  To assist the billing of clinical trials.  To assist with archiving of clinical trial records as required.

Outcome Measures:  Able to perform administrative duties when requested.

General responsibilities are:

Policies and Procedures All pharmacy staff must act in accordance with all relevant legal, Austin Health, Formulary, Drug & Therapeutics Committee etc. policies and procedures.

Outcome Measure: 1* Any actions which have occurred contrary to policy must be recorded and action taken to minimise future variation from policy. 2* Works in accordance with the Clinical Trials policy and procedures..

Occupational Health and Safety Participation in the pharmacy department occupational health and safety program is mandatory. Report to the management any unsafe work practices, hazards, and near miss incidents and accidents to the management.

Outcome Measure: 3* Annual O&HS target activities are undertaken within the designated time frame. 4* Incidents, clinical issues, hazards, safety risk and near misses are responded to and reported appropriately.

Continuing Education and Competency All pharmacy staff must participate in the training and assessment processes including relevant competency assessments in the area of practice. All pharmacists must undertake the continuing professional development (CPD) activities as required by the Pharmacy Board of Australia. All pharmacists must participate in the Austin Health pharmacist continuing education program. All pharmacists must participate in an ongoing competence assessment program (shpaclinCAT) as part of an overall staff development program

Outcome Measures:  Training and assessment in the area of practice completed and satisfactory. 1* CPD requirements are met. 2* Present at least one CE lecture a year according to the Austin Health Pharmacist CE roster. 3* shpaclinCAT evaluation completed annually

Other Responsibilities  Other duties as required. All Employees  Comply with Austin Health policies & procedures, as amended from time to time, which can be located on the intranet (The Hub): http://eppic/  Participate in Austin Health’s annual Performance Review and Development (PRD) program as required.  Engage in processes to monitor service delivery and participate in improvement activities.  Undertake not to reveal to any person or entity any confidential information relating to patients, employees, policies, and processes and do not make public statements relating to the affairs of Austin Health without prior authority of the Chief Executive Officer  Report incidents or near misses that have or could have impact on safety - participate in identification and prevention of risks.  Participate in the emergency incident response activities as directed.

Key Selection Criteria (what are the key qualifications, skills, experience & attributes are required to perform in this role?) Essential for Performance of the Position 1. Registered as a pharmacist with Australian Health Practitioners Registration Authority (AHPRA). 2. Practical knowledge of and experience in conducting clinical trials. 3. Previous hospital pharmacy experience. 4. Well developed clinical pharmacy knowledge. 5. Capacity to perform under pressure, to meet time constraints and determine work priorities. 6. Effective and courteous communication skills. 7. Proven ability to use initiative, identify and solve problems. 8. Proven ability to forward plan, establish and complete targets. 9. Customer focus approach to work and service quality. 10. Reliable and show due care and attention to accuracy and detail. 11. Proficient in computer applications 12. A commitment to Austin Health values: Integrity, Accountability, Respect and Excellence.

Selection Criteria (highly desirable): 1. Previous hospital experience in clinical trials. 2. Previous hospital experience in haematology and oncology. 3. Post-graduate qualifications (pharmacy related). 4. A broad range of experience in hospital pharmacy.

Other Relevant Information (Other information to be made known to persons interested in appointment to this position) Pre-Existing Injury Prior to any person being appointed to this position it will be required that they disclose full details of any pre-existing injuries or disease that might be affected by employment in this position.

Immunisation Maintain appropriate levels of immunisation in accordance with Austin Health’s Workforce Immunisation/Screening Policies, in the interests of yourself, all Austin Health staff, patients and visitors.

Austin Health Values The Austin Health values play a critical role in shaping how we operate as an organisation. They influence our performance, planning, recruitment, training and development, along with our relationships with colleagues, patients and their relatives and friends. The Austin Health values set the standard that we expect all staff to live up to in the way they undertake their role and responsibilities across the organisation, our values:

Integrity We work in the spirit of collaboration and honesty to build effective working relationships across the whole organisation. Position Description Template Revised: June 2016 Page 5 of 7 Accountability We are transparent, responsible and build trust by fulfilling promises and communicating effectively. Respect We care about others and treat each other with consideration, equality and fairness. Excellence We continually strive to advance patient focused care through innovation, research and effective stakeholder management.

Austin Health is a Bully Free and Smoke Free Employer

Austin Health is committed to providing employees with a healthy, smoke free work environment where bullying and harassment does not occur. Consistent with this and Austin Health’s corporate values of integrity, accountability, respect and excellence, Austin Health will not tolerate employees:

 Behaving in a bullying or harassing manner in the workplace; or  Smoking on Austin Health premises or in Austin Health vehicles.

Austin Health is an equal opportunity employer and is committed to attracting and retaining a diverse workforce that reflects the community we serve. Austin Health is committed to providing an inclusive culture where all employees can contribute to the best of their ability. Document Review Details

Review date of Position Description: November 2019

Manager Signature:

I, ______(employee name), have read, understood and accept the content in this position description.

Employee Signature:

Position Description Template Revised: June 2016 Page 7 of 7