Clinical Project Coordinator

2 weeks ago


Melbourne, Victoria, Australia GenesisCare Full time

About the Role


We are seeking an experienced Clinical Project Assistant to join our team at GenesisCare.


This is a permanent full-time position, working Monday-Friday remotely.


As a Clinical Project Assistant, you will provide project-related support for clinical research studies, ensuring that projects are conducted in accordance with applicable standard operating procedures.


You will work closely with Senior Project Managers and other team members to ensure efficient project delivery from proposal development to final study deliverables and archiving.



Key Responsibilities



  • Support the Senior Project Managers and other project team members in implementing tasks and responsibilities.
  • Track, measure, and evaluate project metrics to implement efficiencies.
  • Suggest recommendations to address inefficiencies.
  • Prepare and collect study documentation in conjunction with CRAs and PMs prior to study setup and maintain collection during study.
  • Formulate and maintain a project-specific training matrix in collaboration with Senior Project Managers.
  • Develop, print, ship, and track study binders such as Investigator Site Files.
  • Support project finance, including set-up and maintenance of forecasts, tracking actuals, and invoicing.
  • Set up and maintain Trial Master Files (TMF) and assist with audits.
  • Collaborate in the design, development, and maintenance of Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF).
  • Participate in user acceptance testing (UAT) and computer system validation (CSV).
  • Update CTMS operations guide with project-specific information.
  • Suggest system enhancements to the development team.
  • Manage protocol deviation tracking, client evaluation, and documentation.
  • Develop methodology for site training documentation and interfaces with clients.
  • Develop project-specific working practices.
  • Maintain support responsibility, including scheduling, agenda updates, meeting minutes for project team meetings, and other functional meetings.
  • Provide project administrative support, including meeting minute documentation, monthly reports, shipping, filing, tracking, and status summarization.
  • Assist in planning and creation of client and investigator meetings and related materials.
  • Prepare study kits, if required.


Requirements


To be successful in this role, you will have:



  • An undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
  • At least two years' experience in a clinical research setting, preferably with experience in a CRO.
  • Experience in CTMS and eTMFs is desirable.
  • A solid understanding and practical knowledge of ICH-GCP requirements is preferred.
  • The ability to work in an international environment with internal and external team partners.


What We Offer


As a Clinical Project Assistant at GenesisCare, you can expect:



  • A competitive salary: AU$80,000 - AU$110,000 per year, depending on experience.
  • Internal and external training and development opportunities.
  • Access to free confidential support, including financial, nutritional, and wellbeing coaching, legal advice, and counseling.
  • A range of benefits, including Qantas membership discount, Anytime Fitness Gym membership discount, 12 weeks paid parental leave, and Bupa discount.


About GenesisCare


GenesisCare is 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.


Join us to design better care and enjoy a career with purpose.



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