Senior Clinical Research Associate

4 weeks ago

Brisbane, Queensland, Australia Pharmiweb Full time
Job Title: Senior Clinical Research Associate

Job 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 responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.

  • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites.
  • Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
  • Provides regular site status information to team members, trial management, and updates trial management tools.
  • Completes monitoring activity documents as required by SOPs or other contractual obligations.
  • Escalates site and trial related issues per SOPs until identified issues are resolved or closed.
  • Performs essential document site file reconciliation.
  • Performs source document verification and query resolution.
  • Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.
  • Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
  • Communicates with investigative sites.
  • Facilitates audits and audit resolution.
  • To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g. protocol amendment submissions, Investigator site budget negotiation.
  • If responsible for supervising other CRAs, schedules and reviews trial tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with vendor's policies, procedures, and SOPs, and ensures HR processes are properly implemented.
  • May support new CRA training
  • Functions independently with minimal oversight required.
  • May serve as subject matter expert for clinical operations on monitoring-related activities.
  • May be assigned to complex studies and/or sites.
  • Provides leadership skills to assigned projects and within the Clinical Operations department.


Qualifications:
  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required.
  • 3 or more years of clinical monitoring experience mandatory
  • Previous experience in monitoring oncology and any other studies would be an advantage
  • Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visit [COV]) preferred.
  • Knowledge of ICH and local regulatory authority regulations regarding drug preferred.
  • Experience in coaching/mentoring other CRAs preferred.


What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.
  • Life assurance
  • Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

  • 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 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

    3 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 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

    4 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

    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 Associate

    2 days ago

    Brisbane, Queensland, Australia KlinEra Global Services Inc Full time

    At KlinEra Global Services Inc, we are seeking a highly skilled and experienced Clinical Research Associate to join our team.About the RoleThis is a challenging and rewarding position that requires strong clinical research expertise and excellent communication skills. As a Clinical Research Associate, you will be responsible for participating in study...

  • Senior Clinical Research Associate

    4 weeks ago

    Brisbane, Queensland, Australia Pharmiweb Full time

    Job SummaryWe are seeking a highly skilled Senior Clinical Research Associate to join our team in Cambridge, MA. As a Senior CRA, you will be responsible for monitoring the progress of clinical studies at investigative sites or remotely, ensuring that clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating...

  • Clinical Research Associate II Specialist

    2 weeks 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

    3 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

    2 weeks 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

    2 weeks 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

    1 week 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...