Why is this Job Description being written? New Position Replacement Position Position re-designed Position not previously described

Transcription

1 Why is this Job Description being written? New Position Replacement Position Position re-designed Position not previously described P O SITION DET AI L S: Position Title: C LI NICAL RESEAR C H OFFICER Division: Wesfarmers Centre of Vaccines & Infectious Disease Department: Implementation Research Position reports to: (role) Program Coordinator Location: include all possible locations 0 Roberts Road Subiaco P O SITION PURPOSE: In one or two sentences briefly summarise the overall purpose of this role, i.e. broadly, what this role does and why The key objective of this role is to facilitate the set up and day to day running of clinical research studies, including ensuring that they are conducted efficiently and in accordance with Good Clinical Practice and the National Statement on Ethical Conduct of Research in Humans.

2 K E Y R E SP ON S IBILIT Y A REAS (Please list in order of importance) Key Position Accountabilities % of Total Role Inputs: What are the key activities or tasks to be carried out? Outputs: What are the expected end results? Measures: Study Coordination 40 Setup and management of clinical research studies including: a) Development and maintenance of study-specific documents b) Effective communication with trial sites to ensure compliance with good clinical practice (GCP) and local standards c) Assistance with developing, updating and reporting on research budgets d) Drafting and coordination of ethics and governance submissions e) Monitoring of recruitment of study participants at clinical study sites f) Monitor study progress (e.g. participant recruitment, safety events) at clinical study sites and implementing strategies to ensure compliance with the study protocol Complete and correct documentation for submissions and/or updates Activities effectively communicated to sites and stakeholders Feedback from sites and stakeholders, feedback from Program Coordinator Quality Management 20 Participation in continuous quality improvement and good clinical practice compliance activities Implement and maintain quality management system for clinical trials Develop and maintain group -specific Standard Operating Procedures for management of Clinical Trials Quality Management system and associated documentation Feedback from Principal Investigator and Program Coordinator Data Management Work with the study team to develop case report forms (CRFs) and associated documents Work with the study team to develop clinical study database Set up and manage CRF and enrolment tracking systems Review and validate data in accordance with the data management plan Clarify and answer data related questions with site staff Coordinate safety reporting procedures in accordance with the protocol and Data Safety Monitoring Committee (DSMC) charter Coordinate communications with DSMC Full data compliance, full documentation of data and tracking system 0% compliant database and tracking system, feedback from Program Coordinator

3 K E Y R E SP ON S IBILIT Y A REAS (Please list in order of importance) Key Position Accountabilities % of Total Role Inputs: What are the key activities or tasks to be carried out? Outputs: What are the expected end results? Measures: Information Management Management of the trial master file (TMF) ensure essential documents are filed and kept up to date per Good Clinical Practice and other applicable regulatory guidelines. Management of electronic documentation Trial master file complies with regulatory requirements for essential documents for the conduct of a clinical trial Low query rate after review of TMF contents by Program Coordinator and/or sponsor personnel Ethics and governance procedures Assist Principal Investigator with preparation of applications for ethical, regulatory and governance approval for new studies and subsequent reporting activities Quality ethics application Feedback from Principal Investigator Other Other duties as directed by the Program Coordinator or Chief Investigator N/A N/A E SSENTIAL SKI LLS, KN O W LE DG E A ND EXPE RI ENCE: Qualifications: what are the minimum educational, technical or professional qualifications required to competently perform role Skills, Knowledge & Experience: Bachelor degree in biological sciences, allied health, nursing or other relevant discipline OR equivalent work experience Experience in a clinical research environment, preferably across different phases of development Knowledge of GCP and applicable regulatory guidelines Ability to work independently, take initiative, communicate and work within a team Ability to be highly organised, with a proven ability to prioritise tasks appropriately in a busy working environment Excellent interpersonal, verbal and written communication skills Evidence of well-developed problem-solving ability Ability to apply meticulous attention to detail A high level of computer literacy including word processing, spreadsheets and databases Ability to be flexible with working hours and travel interstate/overseas depending on study requirements

4 D E SIRA BLE S K ILLS, KN O W LE DG E A ND EXPE RI ENCE: Qualifications: what are the minimum educational, technical or professional qualifications required to competently perform role Skills, Knowledge & Experience: SCOPE: Registered allied health, nursing or other clinical professional Previous experience in a hospital/ clinical environment Previous experience in a paediatric research or care environment Familiarity with hospital medical records, medical terminology and confidentiality/privacy requirements GCP or clinical trials accreditation/qualification Dangerous Goods Handling Certificate Previous experience in clinical data management Knowledge and/or experience in quality assurance methods for clinical research Previous experience in infectious diseases / vaccinology Financial accountability: Does this role have accountability for a budget? No People responsibility: Does this role have any direct reports or indirect reports (through direct reports)? No. of direct reports 0 No. of indirect reports 0

5 O R GANISATIONAL C HA RT : Next level of supervision Deputy Team Leader Immediate level of supervision Program Coordinator Other roles reporting to immediate supervisor Research Support Clinical Research Clinical Research Support (x3) Direct reports (role x no.) A D DITION AL INFORMA T I ON: is there any additional information that needs to be understood to explain this role?