Clinical Research Associate

3 weeks ago

Brisbane, Queensland, Australia Pharmiweb Full time
Job Title: Clinical Research Associate - Oncology Trials Specialist

We are seeking a highly skilled Clinical Research Associate to join our team in Northern California, Oregon, or Washington state. As a Clinical Research Associate, you will be responsible for working on multiple trials within Oncology, with a focus on start-up activities.

Key Responsibilities:

  • Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
  • Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.
  • Build strong relationships with site personnel to facilitate a smooth onboarding process.
  • Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).
  • Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.
  • Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.
  • Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.
  • Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.
  • Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
  • Proactively identify and address any issues that may delay study initiation or affect trial deliverables.
  • Maintain precise documentation to ensure readiness for inspections.
  • Support sites during the activation phase until they achieve "Green Light" status for site opening.
  • Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met.
  • Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards.

Requirements:

  • Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences.
  • Must be located in Northern California, Oregon, or Washington state near a major airport.
  • Have a minimum of 2-3 years' experience in monitoring pharmaceutical industry clinical trials.
  • Have a minimum of 1-3 years' experience monitoring Oncology trials.
  • Knowledge of several therapeutic areas.
  • Analytical/risk-based monitoring experience is an asset.
  • Ability to actively drive patient recruitment strategies at assigned sites.
  • Ability to partner closely with investigator and site staff to meet all of our study timelines.
  • Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
  • Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face.
  • Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
  • To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

What We Offer:

  • Competitive salary range ($89,376.00 USD - $111,720.00 USD).
  • A range of additional benefits, including various annual leave entitlements, health insurance offerings, competitive retirement planning offerings, and more.

About Us:

At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

https://careers.iconplc.com/reasonable-accommodations

  • Clinical Research Coordinator

    4 weeks ago

    Brisbane, Queensland, Australia Icon Research Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our team at Icon Research. As a Clinical Research Coordinator, you will play a critical role in the conduct and management of clinical trials, ensuring that research is conducted in accordance with Good Clinical Practice and Icon policies.Key...

  • Clinical Research Associate

    4 weeks ago

    Brisbane, Queensland, Australia Pharmiweb Full time

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a pivotal role in leading the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of innovative treatments and therapies.Key ResponsibilitiesLeading the...

  • Clinical Research Coordinator

    4 weeks ago

    Brisbane, Queensland, Australia Icon Research Full time

    About the RoleWe are seeking a highly skilled Clinical Research Coordinator to join our team at Icon Research. As a key member of our clinical trials unit, you will be responsible for coordinating and conducting clinical trials in oncology and haematology.Key Responsibilities:Provide high-level support to Icon Principal Investigators in the conduct and...

  • Clinical Research Associate

    2 weeks ago

    Brisbane, Queensland, Australia Thermo Fisher Scientific Full time

    About the RoleThermo Fisher Scientific is seeking a skilled Clinical Trial Coordinator to join our team. As a key member of our clinical operations team, you will play a critical role in supporting the planning and execution of clinical trials.Key ResponsibilitiesProvide administrative and technical support to ensure the smooth execution of clinical...

  • Clinical Research Associate Senior

    4 weeks ago

    Brisbane, Queensland, Australia Pharmiweb Full time

    Job Title: Clinical Research Associate SeniorAbout the Role:At ICON, we are seeking a highly skilled Clinical Research Associate Senior to join our team. As a Clinical Research Associate Senior, you will be responsible for identifying, selecting, initiating, and closing out investigational sites for clinical studies in phases II - IV, ensuring adherence to...

  • Clinical Research Specialist

    3 weeks ago

    Brisbane, Queensland, Australia Research at Icon Group Full time

    Role OverviewResearch at Icon Group is seeking a highly skilled Clinical Research Coordinator to join our team at the Icon Cancer Centre, Wesley. As a valued member of our research team, you will play a crucial role in the coordination and conduct of clinical trials in Oncology and Haematology.About the RoleAs a Clinical Research Coordinator, you will...

  • Clinical Research Coordinator

    3 weeks ago

    Brisbane, Queensland, Australia Icon Research Full time

    About the Role:Icon Research is seeking a highly skilled Clinical Research Coordinator to join our team at the Icon Cancer Centre, Wesley. As a Clinical Research Coordinator, you will play a crucial role in the conduct and day-to-day management of clinical trials.Key Responsibilities:Provide high-level support to Icon Principal Investigators in the conduct...

  • Clinical Research Coordinator

    3 weeks ago

    Brisbane, Queensland, Australia Icon Research Full time

    **Contribute to groundbreaking cancer research at Icon Research**As a Clinical Research Coordinator, you will play a crucial role in the success of our clinical trials in Oncology and Haematology.**Key Responsibilities:**Provide high-level support to our Principal Investigators in the conduct and day-to-day management of clinical trials.Manage and conduct...

  • Clinical Research Coordinator

    4 weeks ago

    Brisbane, Queensland, Australia Icon Research Full time

    About the RoleWe are seeking a highly skilled Clinical Research Coordinator to join our team at Icon Research. As a key member of our research team, you will be responsible for coordinating and conducting clinical trials in Oncology and Haematology.Key Responsibilities:Provide high-level support to Icon Principal Investigators in the conduct and day-to-day...

  • Clinical Research Coordinator

    3 weeks ago

    Brisbane, Queensland, Australia Icon Research Full time

    About the RoleWe are seeking a highly skilled Clinical Research Coordinator to join our team at Icon Research. As a key member of our research team, you will be responsible for coordinating and conducting clinical trials in Oncology and Haematology.Key Responsibilities:Provide high-level support to Icon Principal Investigators in the conduct and day-to-day...

  • Clinical Research Associate II Specialist

    1 week ago

    Brisbane, Queensland, Australia Pharmiweb Full time

    Clinical Research Associate II SpecialistWe are seeking a highly skilled Clinical Research Associate II Specialist to join our team in the Czech Republic. This role will involve conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.Job DescriptionConduct site qualification, initiation, monitoring, and close-out...

  • Clinical Research Coordinator

    2 weeks ago

    Brisbane, Queensland, Australia Icon Group Full time

    About the RoleWe have an exciting opportunity for a Clinical Research Assistant to join our team at Icon Cancer Centre Townsville. This part-time role will be responsible for supporting research activities at the site.This is an amazing opportunity to be involved in a change to our research team at a site level and complement a growing trials portfolio. You...

  • Clinical Research Coordinator

    2 weeks ago

    Brisbane, Queensland, Australia Icon Group Full time

    Clinical Research AssistantIcon Group is seeking a highly motivated and organized Clinical Research Assistant to support our research operations and clinical trials at our cancer treatment centre in Townsville.The successful candidate will work closely with our research staff to coordinate and conduct the day-to-day management of administrative tasks...

  • Clinical Research Associate I Specialist

    1 week ago

    Brisbane, Queensland, Australia Pharmiweb Full time

    Job SummaryWe are seeking a highly motivated and experienced Clinical Research Associate I to join our team at Pharmiweb. The successful candidate will be responsible for conducting site qualification, site initiation, interim monitoring, site management, and close-out visits, ensuring compliance with regulatory requirements and company SOPs.Key...

  • Clinical Research Project Manager

    1 week ago

    Brisbane, Queensland, Australia Pharmiweb Full time

    About the Role:Parexel FSP is seeking a highly motivated and skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for managing and supervising oncology studies, working closely with industry leaders and subject matter experts.Key Responsibilities:Manage and supervise oncology studiesWork with...

  • Clinical Research Associate II

    4 weeks ago

    Brisbane, Queensland, Australia Pharmiweb Full time

    Study Start Up Associate IIAt ICON, we're committed to fostering an inclusive environment that drives innovation and excellence. We're seeking a Study Start Up Associate II to join our diverse and dynamic team.Key Responsibilities:Lead the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions,...

  • Clinical Research Associate

    4 days ago

    Brisbane, Queensland, Australia Icon Group Full time

    Icon Group is a leading private cancer clinical trials program in Australia, with over 35 years of experience and a growing global reach. We are seeking a skilled Clinical Research Assistant to join our team in Townsville.About the RoleThis part-time role involves supporting research activities at our centre, located within the Icon Cancer Centre Townsville....

  • Clinical Research Coordinator

    4 weeks ago

    Brisbane, Queensland, Australia Icon Group Full time

    About the RoleWe are seeking a highly organized and detail-oriented Clinical Research Assistant to support our research operations and clinical trials at our cancer treatment centre in Townsville. As a key member of our research team, you will be responsible for coordinating and conducting administrative tasks associated with clinical trials, including...

  • Clinical Research Coordinator

    3 weeks ago

    Brisbane, Queensland, Australia Icon Group Full time

    About the Role:We are seeking a highly organized and detail-oriented Clinical Research Assistant to support our research operations at our Icon Cancer Centre in Townsville. As a Clinical Research Assistant, you will play a crucial role in the day-to-day management of administrative tasks associated with clinical trials.Key Responsibilities:Collect, process,...

  • Senior Clinical Research Associate

    4 weeks ago

    Brisbane, Queensland, Australia Pharmiweb Full time

    Job Title: Senior Clinical Research AssociateJob Summary: ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Job Responsibilities: The CRA is...