Senior Clinical Research Associate

1 month ago

Melbourne, Australia GenesisCare Full time

Your life’s best work

GenesisCare CRO is a full-service oncology CRO specialising in radiopharmaceutical development. We help pharma and biotech companies accelerate drug development, facilitate collaborative research efforts, bridge the translational gap, enhance diagnostic capabilities, and engage a global network of medical experts.

We are currently looking for a Senior Clinical Research Associate for the CRO division of the business to be based in either Sydney, Melbourne or Brisbane. This role will take responsibility for monitoring clinical trials ensuring that projects are conducted in accordance with applicable SOPs, regulations and ICH guidelines.

You will be responsible for all aspects of the study at sites and ensure that the Project Managers (PM) are kept fully informed of all aspects of the project. You will also ensure that project documentation is obtained and maintained in a timely and compliant manner accordingly to project requirements. The Senior CRA may also serve in the Lead CRA role and provide guidance to CRAs or assist with PM related tasks.

What you’ll do:

  • Act as a member of the project team with the goal to contribute towards efficient management of trials.
  • Perform Site Qualification Visits: discusses protocol, other available study documentation and study requirements with Investigator and other trial staff, ensures that trial staff and site facilities and the site’s recruitment potential are in accordance with protocol requirements, local regulations, ICH-GCP and GC CRO’s SOPs
  • Support feasibility, site selection and start up activities, including leading the preparation of Human Research Ethics Committee (HREC) submissions with sites.
  • Negotiate site budgets and assists with the execution of site contracts with support from the PM.
  • Perform Site Initiation Visits: trains Investigators and other trial staff in the protocol and data collection methods to ensure collection of patient data is accurate, complete, and conforms to protocol requirements, in accordance with local regulations, ICH-GCP and GC CRO’s SOPs.
  • Perform Interim Monitoring Visits: ensures adherence to protocol, monitor participant source data via source document verification per the monitoring plan, and perform Investigational Product accountability, meet with site staff and ensure study procedures are conducted in according with the protocol and ICF GCP.
  • Perform Site Close Out Visits.
  • Oversee all aspects of study site management to ensure high quality data
  • Maintain eTMF filing.
  • Maintain study tracking in Clinical Trial Management System (CTMS) in a timely manner.
  • Manage timely site payments.
  • May be delegated with PM related tasks, where appropriate.

We’re Looking for Someone Who Has:

  • An Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
  • At least 3-4 years’ experience in monitoring clinical trials in CRO (preferable), Pharmaceutical and/or Biotechnology industry as a SCRA/CRA.
  • Experience in managing early phase oncology trials is highly preferred
  • Experience in EDC & CTMS
  • Experience in all aspects of site-management from feasibility, start-up site selection to site close-out.
  • Experience in contracts negotiation desirable.
  • Experience in HREC submission preparation.
  • Understanding and practical knowledge of ICH-GCP requirements particularly as required for site management.
  • Willingness to travel to fulfil the requirements of the role.

What’s in it for you:

  • Own your development, learn every day.
  • Opportunities to be exposed to getting involved in early site engagement right from feasibility and start up period to build relationship with site.
  • Opportunities to work directly with sponsor on assigned projects.
  • 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.
  • Enhance your holistic wellbeing with our Full Circle wellbeing program.
  • Range of benefits available: Qantas membership discount, Anytime Fitness Gym membership discount, 12 weeks paid parental leave, Bupa discount.

About GenesisCare
We are 1,300+ highly trained healthcare professionals and support staff in Australia designing innovative treatments and care for people with cancer. Our dedicated teams treat more than 30,000 patients annually.
People centricity is at the heart of what we do whether that person is a patient, a referring doctor, a partner or someone in our team. We aim to build culture of care that is patient focused and performance driven. Our people promise is "do your life's best work, by always growing, having a profound human impact and making great things happen together." If you'd like to make a difference, join us at GenesisCare.

Covid 19 Vaccination Requirement
In line with the Public Health Order, all GenesisCare employees are required to be fully vaccinated for COVID-19. To be eligible for consideration to perform work for GenesisCare, all recruits must provide evidence of vaccination and comply with the requirements of the Public Health Order prior to appointment.

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