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Senior Clinical Research Associate

GenesisCare - Melbourne, VIC

Health, Medical & Pharmaceutical
Source: uWorkin


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.

Do your life’s best work!

We are looking for 2 x Senior Clinical Research Associates to be based in either Sydney or Melbourne. You will take responsibility for monitoring clinical studies 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.

What You’ll Do

  • Act as a member of the project team with the goal to contribute towards efficient management of trials;
  • Negotiate site budgets and assists with the execution of site contracts with support from the legal department and PM;
  • Support recruitment of potential Investigators, and lead preparation of Human Research Ethics Committee (HREC) submissions, notifications to regulatory authorities, translation of study related documentation, organisation of meetings and other tasks as instructed by the PM;
  • Oversee all aspects of study site management to ensure high quality data resulting in consistently low query levels and in good quality assurance reports;
  • Establish update, track and maintains study specific trial management tools/systems, and status reports;
  • Perform pre study 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;
  • 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 site monitoring visits: ensures adherence to protocol, accurate data collection via
  • source document verification per the monitoring plan, and investigational product/biological samples/supplies accountability;
  • Communicate effectively with site personnel, including the Principal Investigator (PI), and GC management to relay protocol/study deviations and ensure timely implementation of corrective actions;
  • Develop and maintain strong working relationship with Investigators and study staff, serving as an ambassador to promote GC's high quality and ethical image;
  • Maintain study tracking, in accordance with the demands of the study;
  • Understand and update Clinical Trial Management System (CTMS) in a timely manner;
  • Monitor and update data in an Electronic Data Capture (EDC) system in a timely manner and in accordance with study specific guidelines;
  • Perform data management review, including in-house CRF review, and alert PMs and data managers to emerging issues with CRF completion;
  • Identify and process Serious Adverse Events (SAEs) according to the procedures defined by the study team;
  • Demonstrate a broad understanding of the SAE reporting process to regulatory authorities;
  • Liaise with data management to resolve data discrepancies and ensure all data management study goals are met;
  • Prepare and perform site closeout visits according to the protocol, local laws, ICH-GCP and GC CRO’s SOPs;
  • Prepare accurate and timely visit reports from all types of visits;
  • May be involved in preparation of status reports for clients;
  • May review protocols, consent forms, eCRFs, study manuals and other study documents, as requested by the PM/management/study team;
  • Conduct feasibility work;
  • Interact with internal work groups to evaluate needs, resources and timelines;
  • Initiate payment requests for Investigators;
  • May serve as mentor for junior CRAs and those new to the company and/or study
  • Perform other duties as assigned by management; and
  • Travel as necessary according to project needs.

Who You Are
  • Undergraduate degree in Life Sciences (e.g., Biology, Chemistry, Pharmaceuticals)
  • At least five years’ experience in monitoring clinical trials in CRO (preferable), Pharmaceutical and/or Biotechnology industry as a SCRA/CRA/Monitor.
  • Experience in EDC & CTMS
  • Experience in all aspects of site-management from 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.
  • Experience working in Oncology and Cardiology therapeutic areas highly preferable
  • Able to work in an international environment with internal & external team partners (including virtual teams) and Asia Pacific/European experience is highly desirable
  • Excellent communication skills, written and oral and good presentation skills
  • Excellent organisation and time management skills
  • Proactivity and risk management skills
  • Excellent computer skills Undertake travel, domestically and internationally to fulfil the requirements of the role

What’s In It For You
  • Own your development, learn everyday
  • The opportunity to work for one of the most influential leaders
  • Work/life balance with opportunities to work from home on occasion

Who We Are

We are 5500+ highly trained healthcare professionals and support staff across Australia, the U.K., Spain, China and the United States, designing innovative treatments and care for people with cancer, heart and sleep disease.

GenesisCare Clinical CRO is an independent company founded by GenesisCare, with people skilled across the full spectrum of traditional CRO service offerings yet connected through GenesisCare to additional research services and investigator sites.

Joining the GenesisCare team means a commitment to seeing and doing things differently. Asking what if and why not? And focused on getting the best possible outcomes for our patients.

Global care

Across the world, we have more than 440+ centres to help us bring the right care to our patients. For radiation therapy, that includes 14 centres in the UK, 21 in Spain, 36 in Australia and 300 in the U.S. We also offer cardiology and sleep services at more than 80 locations across Australia. Every year our team sees more than 400,000 people globally.

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.

GenesisCare is an Equal Opportunity Employer.

Melbourne, VIC

Health, Medical & Pharmaceutical


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