At GenesisCare, we are passionate about innovation and working together to drive better life outcomes for patients around the world.
Our Mission
We are a full-service oncology Contract Research Organisation (CRO) specialising in radiopharmaceutical development. We help pharmaceutical and biotechnology companies accelerate drug development, facilitate collaborative research efforts, bridge the translational gap, enhance diagnostic capabilities, and engage a global network of medical experts.
Refer to our website www.genesiscare.com/cro for more detailed information.
We are currently seeking a Senior Clinical Research Associate to join our CRO division. This role will be based in either Sydney, Melbourne or Brisbane and will involve monitoring clinical trials to ensure they are conducted in accordance with applicable Standard Operating Procedures (SOPs), regulations and International Conference on Harmonisation (ICH) guidelines.
You will be responsible for all aspects of the study at sites and ensure that Project Managers are kept fully informed of all project details. You will also ensure that project documentation is obtained and maintained in a timely and compliant manner according to project requirements. The Senior CRA may also serve as Lead CRA and provide guidance to CRAs or assist with Project Manager related tasks.
Key Responsibilities:
* Act as a member of the project team to contribute towards efficient trial management.
* Perform Site Qualification Visits to discuss protocol, other available study documentation and study requirements with Investigators and other trial staff.
* 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 assist with the execution of site contracts with support from the Project Manager.
* Perform Site Initiation Visits to train Investigators and other trial staff in the protocol and data collection methods.
* Perform Interim Monitoring Visits to ensure adherence to protocol and monitor participant source data via source document verification per the monitoring plan.
* Perform Site Close Out Visits.
* Oversee all aspects of study site management to ensure high quality data.
* Maintain electronic Trial Master File (eTMF) filing.
* Maintain study tracking in Clinical Trial Management System (CTMS) in a timely manner.
* Manage timely site payments.
* May be delegated with Project Manager related tasks, where appropriate.
About You:
* An Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals).
* At least 3-4 years' experience in monitoring clinical trials in CRO, Pharmaceutical and/or Biotechnology industry as a Senior Clinical Research Associate/Clinical Research Associate.
* Experience in managing early phase oncology trials is highly preferred.
* Experience in Electronic Data Capture (EDC) & CTMS.
* Experience in all aspects of site-management from feasibility, start-up site selection to site close-out.
* Experience in contract 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 We Offer:
* Opportunities to own your development and learn every day.
* Opportunities to get involved in early site engagement right from feasibility and start-up period to build relationships with sites.
* Opportunities to work directly with sponsors on assigned projects.
* Internal and external training and development opportunities.
* All employees and their family members have access to free confidential support, including financial, nutritional and wellbeing coaching, legal advice & counselling.
* Enhance your holistic wellbeing with our Full Circle wellbeing program.
* A range of benefits available: Qantas membership discount, Anytime Fitness Gym membership discount, 12 weeks paid parental leave, Bupa discount.
About Us:
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. Our ambition for better cancer care 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.
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.
GenesisCare is an Equal Opportunity Employer.