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Clinical Trial Coordinator
4 months ago
Summary
Part-time (0.6 FTE-1.0FTE), 12-Month Fixed Term Contract
At the South Australian Health and Medical Research Institute (SAHMRI), we are committed to achieving innovative, ground-breaking health and medical research that fundamentally improves the quality of life for all people.
SAHMRI Women and Kids (SWK) are seeking a highly motivated and experienced Clinical Trial Coordinator to manage and lead the the coordination of high quality single and multi-centre trial activities, in adherence with Good Clinical Practice (GCP) and Ethics requirements. In this position, you will work closely with the Trial Leadership Team, broader SWK teams and other staff at SAHMRI and relevant study sites. This diverse role will involve engaging with multiple stakeholders including study participants, health professionals, internal and external investigators as well as study researchers and clinical staff.
About the role
Key responsibilities include:
Assisting with the implementation of the trial protocol as directed by the trial leadership team. Work with the chief investigator and stakeholders to scope and plan project deliverables Liaise and maintain productive relationships including health professional, internal and external investigators, study researchers and clinical staff. Continuously monitor trial processes and recruitment status and recommend improvements to meet project milestones and to adhere to quality standards. Prepare, submit and maintain records of ethics applications for various committees including hospital approval processes Coordinate the development of forms, questionnaires, procedure manuals, trial protocols, CRFs, SOPs and other documents as required. In conjunction with IT experts, actively review and give feedback on the design and development of web-based software to manage clinical trial/s and data collection Manage a schedule of project meetings Prepare meeting materials including agendas, minute taking and the follow up of action items Conduct all aspects SWK clinical trials in accordance with ICH GCP guidelines and the trial protocol. Manage the day to day operations of the project Successfully screen and enrol research participants from various settings to achieve recruitment targets in accordance with GCP guidelines and trial protocol. Ensure samples collected from study participants are collected, processed, recorded, labelled and stored in accordance with trial protocolAbout You
The successful candidate will possess the following key attributes:
Hold a degree in a relevant field Training in ICH-GCP highly desirable Experienced in the coordination and management of clinical trials involving women and children preferable. Proven experience in a clinical trials environment, including recruitment, enrolment and data management. Demonstrated project skills through to completion Excellent planning and organisational skills, with the ability to establish priorities and allocate resources to meet tight deadlines Experience in preparing and submitting ethics and local governance applications preferable Relationship management skills, including the ability to interact with, and gain cooperation from with a variety of stakeholders Experience in the use of project management software and related programs Experience in or knowledge of Australian health/hospital systems and experience in working in a hospital setting, including ability to understand the implications and maintain confidentiality and privacy Knowledge of GCP. Ability to write clear, succinct and accurate reports. Ability to demonstrate flexibility and adaptability in the workplace, including the ability to deal with emerging issues in a timely manner Ability to work within a team environment whilst setting personal targets to achieve required results.Special Requirements
Primarily located at either Women’s and Children’s Hospital or Flinders Medical Centre with some travel required between SWK sites including SAHMRI DCSI Working with Children Checks required. Some out of hours work may be required All employees are required to be immunised in accordance with the requirements of the Hospital in which they are working or be willing to be vaccinated at the cost of the Institute.