Clinical Research Associate

4 weeks ago

Gold Coast, Queensland, Australia Pharmiweb Full time
Job Description

As a Clinical Research Associate, you will be responsible for managing clinical trials in the oncology field. Your primary goal will be to ensure the smooth execution of trials, from site qualification to activation and maintenance.

Key Responsibilities
  • Conduct site qualification visits to assess the eligibility of sites for participation in clinical studies.
  • Collaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.
  • 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 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
  • A minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences.
  • Must be located in IL/IN/MO near a major airport.
  • Must have 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

At ICON, we value our employees and offer a range of benefits to support their well-being and work-life balance. Our benefits include:

  • Various annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

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

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

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