Staff Member Signature Date Direct Supervisor Related Mater Health Services Position Description attached. Theme Leader Signature Date.

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1 POSITION DESCRIPTION Mothers and Babies Theme Position Title Division Position Purpose Position Scope Occupational Category and Level Reporting Relationship Review Date Next Review Due, Mothers and Babies Theme Clinical Research Support Unit Mothers and Babies (MnB) Theme MMRI The supports the implementation and conduct of clinical research to ensure the high quality and timeliness of Mothers and Babies Theme Research ensuring that relevant local, national and international regulations and standards are being met. Provides direct line-management of junior clinical research coordinators within the MnB Theme as required. Responsible for the implementation of clinical processes, systems and educational tools. Promotes and supports evidence based health care at the Mater Health Service (MHS) through clinical research. All clinical research studies utilising human research subjects in the Mothers and Babies Theme Level NO2.4/MMRI Level 8 The position reports directly to Theme Leader Staff Member Signature Date Direct Supervisor Related Mater Health Services Position Description attached Theme Leader Signature Date Yes ref: N/A Page 1 of 5

2 1. OVERVIEW The MMRI is responsible for the implementation and coordination of research studies relevant to the Mothers and Babies Theme. The Senior Clinical Research Coordinator is responsible to ensure timeliness of the scheduling of clinical research procedures required by research protocols. In addition, the is expected to evaluate the performance of and promote the career development of relevant Clinical Research Coordinators. The position will liaise with the Clinical Research Support Unit to ensure studies are conducted to a high standard in accordance with MMRI policy. 2. HOURS Working hours are to be agreed with one s supervisor. As with all scientific institutes, the MMRI acknowledge the need for flexibility in working hours in order to complete individual projects and assigned responsibilities. The MMRI does not require recording of hours worked. The MMRI finds this flexibility contributes to our overall team effort and success. 3. PURPOSE OF THE POSITION The supports the implementation of clinical programs within the relevant theme to ensure the high quality and timeliness of Mater Clinical Research relevant to the Mothers and Babies Theme including multicentre clinical trials at the MMH. Supports the conduct of clinical studies whilst ensuring that the applicable local, national and international regulations and standards are being met. Provides direct linemanagement of relevant Clinical Research Coordinators. Responsible for the implementation of clinical processes, systems and educational tools. Promotes and supports evidence based health care at the Mater Health Service (MHS) through clinical research. 4. POSITION DESCRIPTION 4.1. Clinical Research Activities Ensure that each study is completed as required per project timelines/recruitment and allocated funds including maintenance of recruitment logs in collaboration with the Mater principle investigator Liaise with clinical staff and investigators to develop strategies to meet enrolment projections as required per project timelines for each study Liaise with external research entities as required to ensure multicentred studies are undertaken effectively Liaise with the CRSU to ensure Service Line Agreements are managed effectively Provides regular reports on research activity to relevant Principle Investigators and Theme Leader as required Conducts clinical research to ensure consistency and adherence to Good Clinical Practice (GCP) and all applicable regulatory requirements Responsible for the adherence to MMRI/MHS Clinical Policies which include expedited reporting to the HREC when required, and to the regulatory authority(ies) of all adverse drug reactions that are both serious and unexpected (as per ICH GCP 5.17 and 5.18) Identify and resolve issues associated with the conduct of clinical research in collaboration with the MMRI/MHS staff, clinicians, external investigators, external sites and collaborators Ensure that the HREC receives required trial reports, any protocol amendments and safety reports as required Page 2 of 5

3 Participates in the writing and review of HREC submissions, amendments and progress report Assist in the development of position descriptions and recruitment for the junior Clinical Research Coordinators and implementation of standard operating procedures Identify emerging trends/regulations in clinical research while proactively integrating these elements into policies and procedures within the relevant theme 4.2 Education and Communication Assist in the development of training programs for internal resources Development and maintenance of an induction manual for new research coordination staff Demonstrate a high standard of written and oral communication and interpersonal skills Establish and maintain effective communication networks to facilitate efficient conduct of clinical research with relevant collaborators and/or industry sponsors within the relevant theme Promote consumer awareness of the role of clinical research within the MHS complex and externally Prepare and present at professional forums as applicable Attend relevant and mandatory educational programs, workshops, conference and promotional functions Responsible for updating education training record that is maintained in personnel file Maintain currency with the relevant discipline s educational practice and industry requirements 4.3 Human Resource Management Maintain a safe working environment Report any potential hazards to the reporting officer Ensure compliance with Workplace Health and Safety (WHS) Standards. Treat all clients with sensitivity and without discrimination Responsible to ensure that junior Clinical Research Coordinators have the adequate resources to meet the needs of the MnB Theme and other relevant research Responsible to ensure that direct reports are informed of and have completed training on all applicable Standard Operating Procedures (SOPs) Responsible to ensure that each direct report has an annual performance development plan which provides the basis for annual performance evaluation 4.4 Expression of the Mater Values Promote and demonstrate the mission and objectives of MMRI Limited Promote and demonstrate the philosophy and values of the Sister of Mercy Demonstrates personal attentiveness, sensitivity and non-judgemental manner when interacting with team members and families Demonstrate values based decision-making and leadership Ensure that the mission, objectives, philosophy and values stated above are inherent in the delivery of health care services by collaborating with and supporting other members of the health care team regarding clinical and research practices Demonstrate a strong commitment to the timely delivery of a high quality service to the staff of MMRI Define develop and implement strategic objectives based on sound decision making and internal and external key performance indicators Liaise with both internal and external stakeholders to ensure quality outcomes Page 3 of 5

4 5. PRIMARY DELEGATIONS AND ACCOUNTABILITIES Liaise with MnB Theme Leader and CRSU to identify key internal and external factors affecting the conduct of clinical research within the theme and develop recommendations to address these factors Develop a strong working relationship with relevant departments within and acoress relevant themes to ensure effective implementation of clinical research Develop and implement communication strategies that inform, link and bond MHS/MMRI with the Clinical Research Coordination team relevant to MnB Theme to facilitate information exchange 6. INTELLECTUAL PROPERTY The MMRI will require the assignment of all rights, in and to all discoveries, and inventions made, developed, or devised while working at or under the guidance of the MMRI, during the term of the appointment. The will be required to sign documents, which vest ownership of such discoveries and inventions, to the MMRI, enabling the Institute to become registrable as the holder of the registered designs and patents. 7. QUALIFICATIONS The will be required to have a clinical background or experience in perinatal clinical area and relevant qualification or equivalent experience in implementing and conducting clinical research including ethics proposals and documentation, excellent written and communication skills, advanced computer skills, ability to work independently and as part of a multidisciplinary team and a high level of interpersonal and organisation skills. A higher degree with a research component is desirable. 8. PERSONAL QUALITIES Personal attributes of integrity, tact, sound judgement and respect for confidentiality. Express a commitment to the promotion of the philosophy and objectives of the Sisters of Mercy and the MMRI. 9. REVIEW The position will be subject to mutual positive review on an annual basis. Page 4 of 5

5 10. SELECTION CRITERIA DESIGNATION: LOCATION: CLASSIFICATION: Clinical Research Support Unit, Mater Medical Research Institute SC1. SC2. SC3. SC4. SC5. SC6. SC7. A completed relevant qualification, or have equivalent qualifications of clinical research experience. Demonstrate ability to perform independent clinical research duties with skills appropriate to this appointment. Establish work priorities and set realistic goals, meet deadlines and organise a work environment ensuring team participation. Demonstrated high level of interpersonal and written communications skills and the ability to maintain confidentiality. Demonstrated understanding and commitment to the joint NHMRC/AVCC Statement, Guidelines on Research Practice and other applicable local, national and international regulations. Demonstrated understanding and commitment to the NHMRC National Statement on Ethical Conduct in Research and Clinical Trials Involving Humans. An understanding of or ability to acquire knowledge of the human resource management issues including Workplace Health and Safety, Equal Employment Opportunity and Anti-Discrimination. Employee Name: Signature: Date: / / Direct Supervisor Name: Signature: Date: / / Page 5 of 5

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