Position Description. Lower Level 1 Clinical Trials Unit Clinical Trials Unit (CTU) Division of Cancer Medicine. Direct: CTU Trials Unit Manager

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1 Business Unit: Clinical Trials Research Unit Position Description Job Title Grade/Classification Award Location Department Cost Centre Reporting To: Senior Clinical Trials Research Nurse YX13 Nursing Lower Level 1 Clinical Trials Unit Clinical Trials Unit (CTU) Division of Cancer Medicine Y3308 Direct: CTU Trials Unit Manager Indirect: CTU Department Head Main Purpose of Position Key Effectiveness Areas Number of Direct Reports nil Responsible for the conduct of Clinical Trials within in the Department of Haematology & Medical Oncology. Coordinate the delivery of direct and indirect care and associated data collection for concurrent research studies undertaken in the department, in accordance with the Therapeutic Goods Administration (TGA) Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) and the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Research Involving Humans. Responsible for mentoring, education and development of team members Management of clinical research trials Professional Development Education Decision Making Authority Key Relationships nil Internal: Members of own team within CTU and their education, support, mentorship and development Research participants & their carers Multidisciplinary team members. Clinical Trials Unit Staff All Peter Mac Clinical Research staff Clinical nurses in all relevant patient care areas - including CDU, OPD, ward nurses, diagnostic imaging nurses Principal Investigators, Co-investigators and associated clinical trial medical staff Diagnostic imaging and nuclear medicine department staff Pathology Department staff Pharmacy Department staff Data managers and BaCT Health information department Clinical Research Committee & Ethics Committee and the secretariat External: Trial sponsor representatives including clinical research Page 1 of 7

2 Cancer Trials Australia Research nurses and data managers at other hospitals External laboratories Professional bodies such as VCOG & COSA & ARCS Experience/Qualifications Performance Objectives 1. To effectively manage clinical research trials Essential: Current registration with the Nurses Board of Victoria (or ability to become registered if international candidate), with a minimum of 5 years post graduate nursing experience, with at least 2 of those in Oncology/Haematology, or relevant experience demonstrating the appropriate competencies and skills for the job and clinical setting. Two years clinical trials experience in Oncology/Haematology Degree level education or other relevant further education. Evidence of further education including post-graduate certification/diploma/continuous professional development in a relevant area Personal integrity and discretion. Demonstrated excellent team working skills with ability to work using own initiative. Ability to have oversight of a team of clinical trials staff dedicated to tumour streamed clinical trial management Effective listening and interpersonal skills. Time management skills/ability to prioritise workload. Comprehensive IT skills. Research experience including working knowledge of Australian statutory and regulatory requirements including - TGA ICH GCP Guidelines, NHMRC Act 1992 and the Privacy Key Performance Indicators Ensure conduct clinical research trials is in accordance with TGA ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans. Demonstrate knowledge of each research protocol including procedures and documentation to ensure the safe and accurate conduct and recording of the study. Able to make appropriate professional autonomous decisions as required & seek clarification where necessary. Provide professional advice relating to the conduct of clinical research to the Investigator, multidisciplinary team and CTU team that is in accordance with TGA ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans, unit operating procedures & hospital policy. Maintain a flexible approach to working hours in order to meet the requirements of research protocols and subject recruitment. Liaise with all involved groups/departments to ensure all biological samples are collected, processed, stored and shipped as per the clinical trial protocol requirements. Participate in clinical trial monitoring/auditing internally and externally as required in order to meet the regulatory and scientific requirements Develop the role by using evidence based practice and continuously improving knowledge following training and education guidelines. Page 2 of 7

3 2. Ensure quality data and patient safety at all times 3. To undertake & participate in professional development & education Page 3 of 7 Assist in ensuring that all staff within own team and within the unit are given the professional development they need to gain the expertise needed to co-ordinate clinical trials. Work effectively with sponsor representatives (CRAs) during monitoring of clinical trial data, internal company audits and external reviews. Demonstrated ability to manage workload to ensure interests of patients on clinical trials are met and protocol requirements are followed. Able to maintain effective communication processes with patients and carers, investigators, and other members of the multidisciplinary team to ensure information is appropriately shared. Work within and monitor standards of care in the defined clinical trial protocols, SOPs and practice guidelines of the clinical trials unit, hospital policies & procedures to ensure adherence to and delivery of, a high quality service. Contribute to the development of policies and procedures within the clinical trial unit & organisation to ensure that clinical research practice is underpinned by current best practice. Ensure that studies are undertaken in accordance with the terms approved by the institutional ethics committee and 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. Demonstrates knowledge of each designated clinical trial protocol including procedures and documentation to ensure the safe and accurate conduct and recording of the study. Uses practice guidelines and study specific documentation to ensure that data is recorded accurately and in accordance with regulatory requirements. Able to screen/register only appropriate patients for clinical trials as per clinical trial eligibility criteria. Follow patients as per protocol and, where necessary, facilitate participant withdrawal from a study in order to ensure the patients best care and the effective achievement of the study aims. Ensures informed consent is obtained according to standard hospital practice, ICH GCP and the NHMRC National Statement on Ethical Conduct in Research Involving Humans and be actively involved in the ongoing informed consent process. Participate in the teaching of nursing & medical staff and other members of the multidisciplinary team and own CTU team in regard to clinical research and associated guidelines & regulations. Demonstrates a commitment to personal continuing professional development and participate in performance review/appraisal. Undertakes additional training in order to acquire the knowledge and skills needed to implement new study protocols from a variety of clinical specialities Maintain up-to-date clinical skills and knowledge delivering care to allocated study clinical trial patients. Maintain mandatory training requirements as defined by hospital and nursing policy

4 4. To function as an integral member of the clinical research team Develops & participates in appropriate quality activities Participates in appropriate educational activities Contributes to unit meetings Takes responsibility for ensuring trial patients are seen and protocol requirements are carried out according to protocol and without incident. Able to oversee, mentor, support and educate junior staff to ensure quality, safety & education are promoted. Page 4 of 7

5 Performance Objectives Continuous Quality Improvement Infection Control Adheres to the principles of Infection Control in accordance with Peter Mac policies and procedures Occupational Health & Safety Takes all reasonable steps to ensure a safe environment Understands emergency procedures and location of emergency equipment Key Performance Indicators Complies with Infection Control policies and procedures 100% of the time Completes incident reports 100% of the time and responds appropriately to OH&S incidents Attends Health & Safety training on emergency procedures annually and is capable of identifying emergency equipment in place Direct care staff will attend the yearly update on theory of fire, code red and orange responses and use of extinguishers Privacy Adheres to the Peter Mac privacy policy Follows established procedures Human Resource Management Human Resources Takes all reasonable steps to prevent bullying, discrimination and harassment in the workplace Performance Development & Review Participates in and/or conducts annual performance development and refiew Recruitment & Selection Adheres to Peter Mac policy Performance Management Adheres to Peter Mac policy Complies with Peter Mac policies to maintain a safe work place. Participates and/or conducts annual performance development and review on 100% of staff. Follows established procedures Follows established procedure and guidelines Page 5 of 7

6 Proficiency Level required to be indicated against each value. A= Proficient B= Advanced C= Expert Values Patients and their carers come first We value our people and encourage teamwork through mutual respect and trust We strive for excellence supported by innovation, research and a learning culture Key Behaviours Customer Service Orientation Provides a high standard of service and support to key stakeholders including patients and their families, internal and external customers Uses appropriate communication techniques to accurately determine needs of the customer Maintains positive, professional relationships Actively seeks feedback to better understand needs Follows up to ensure customer satisfaction Excellence Focused on delivering appropriate outcomes Sets appropriate goals/objectives that reflects high expectations for yourself and others Strives to achieve at high levels Communication Exchanges ideas by using suitable language Demonstrates a clear, concise, open manner appropriate for the audience Listens when others are communicating Uses approachable and open body language Teamwork Contributes opinions, encourages others to contribute their opinions and builds on them Involves others to achieve outcomes Engages in collaborative practice with colleagues Works to achieve common goals Accepts responsibility for achieving shared goals Establishes mutual respect and trust Communicates genuinely around topics of mutual interest Builds trust through managing and delivering on expectations Communicates to others that they are valued & important Seeks to build rapport with people Establishes contact regularly Excellence Focused on delivering appropriate outcomes Sets appropriate goals/objectives that reflects high expectations for yourself and others Strives to achieve at high levels Innovation Embraces and contributes to new approaches dealing with work problems or opportunities Ethics Adopts an ethics based approach to all aspects of their work Ensures the highest moral standards are achieved in what we ought to do Proficiency Level Page 6 of 7

7 We embrace the positive effects of change Change Embraces and contributes to new approaches dealing with work problems or opportunities We insist on openness and accountability Communication Exchanges ideas by using suitable language Demonstrates a clear, concise, open manner appropriate for the audience Listens when others are communicating Demonstrates approachable and open body language Problem Solving Identifies and analyses issues, problems and opportunities Develops appropriate solutions, makes use of available tools, demonstrates resourcefulness and takes effective action that is consistent with Peter Mac standards and values We adhere to the strongest ethical standards in both clinical practice and research Ethics Adopts an ethics based approach to all aspects of their work Ensures the highest moral standards are achieved in what we ought to do Signatures Department Head Practitioner CEO Privacy Statement: Information may be collected and stored for the purpose of recruitment and selection. The information will only be used and disclosed for the primary purpose of its collection. Some exceptions exist. These may be obtained from the Privacy Officer. Page 7 of 7