Clinical Project Assistant

At GenesisCare we want to hear from people who are as passionate as we are about innovation and working together to drive better life outcomes for patients around the world. Care to join the team? GenesisCare has an exciting opportunity for a Clinical Project Assistant to join our team, this role can be homebased in Australia. As our Clinical Project Assistant, you will take responsibility for project related support for clinical research studies, ensuring that projects are conducted in accordance with applicable standard operating procedures. You will also support project managers and other team members from proposal development to final study deliverables and archiving. On offer is a permanent full-time position, working Monday-Friday working remotely. More Specifically, You Will

• Supports the Senior Project Managers and other project team members including Senior Data Manager, Senior Clinical Research Associates Physicists, Medical Writer, Medical Monitor/Advisor, and extended team members such as the Head of Clinical Operations and Clinical Quality and Compliance Manager in the implementation of tasks and their responsibilities.
• Supports the Senior Project Mangers in the tracking, measurement, and evaluation of project metrics to implement efficiencies.
• Suggest recommendations to address inefficiencies.
• Prepare and collect study documentation in conjunction with (Snr) CRAs and (Snr)(PM) prior to study set-up and maintain collection of documentation during study.
• Works in conjunction with Senior Project Managers to formulate and maintain a project-specific training matrix. Communicates with the Clinical Quality and Compliance Manager to ensure documentation is filed.
• Drives the development, printing, shipping, and tracking of any study binders such as Investigator Site Files.
• Supporting Senior Project Manager in project finance including set-up and maintaining forecasts, tracking actuals and invoicing.
• Managing the setting up and maintaining of Trial Master Files (TMF). For those projects using an electronic TMF, responsible for emailing/filing project master file documents to the appropriate inbox/folder.
• Assists Senior Project Managers with TMF audits and formulates recommendations for missing components.
• Collaborates in the design, development, and maintenance of Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF).
• Participates in user acceptance testing (UAT) and computer system validation (CSV).
• Updates CTMS operations guide with project specific information.
• Suggests system enhancements to development team.
• Per project requirements, manages protocol deviation tracking, including client evaluation and subsequent documentation. Formulates recommendations to create efficiencies.
• Per project requirements, develops methodology for site training documentation and interfaces with client.
• Per project requirements, develops project specific working practices.
• Maintains support responsibility, including scheduling, managing agenda updates, and meeting minutes for project team meetings and other functional meetings, as assigned.
• Provides project administrative support including meeting minute documentation, monthly reports, shipping, filing, tracking, and status summarization, as appropriate.
• Participate and assist in the planning and creation of client and investigator meetings and related materials.
• Preparation of study kits, if required.

We’re Interested In Hearing From People Who

• Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
• At least two years’ experience in a clinical research setting, with experience in a CRO preferred.
• Experience in CTMS and eTMFs is desirable.
• Understanding and practical knowledge of ICH-GCP requirements is preferred.
• Able to work in an international environment with internal & external team partners (including virtual teams) is desirable.

Benefits Of Joining Our Team

• Working with a vibrant team aligned with providing the best patient experience possible and outcomes.
• Internal and external training and development opportunities.
• All employees and their family members have access to free confidential support that is completely external to GenesisCare including financial, nutritional and wellbeing coaching, legal advice & counselling.
• Learn and grow with our award-winning development programs.
• Range of benefits available: Qantas membership discount, Anytime Fitness Gym membership discount, 12 weeks paid parental leave, Bupa discount

About GenesisCare By joining GenesisCare, you will be joining a highly progressive and passionate team of healthcare professionals and support staff, united by a common purpose: to design care experiences that deliver the best possible life outcomes. The ambition for better cancer care that began our story, has grown into a passionate team of ~2,000 employees across 50 locations nationally. Join us to design better care and enjoy a career with purpose. GenesisCare is an Equal Opportunity Employer.