(Sr.) CRA II

Oncology (Sr.)CRA II, Home-Based, South Korea

As a (CRA II/SCRA) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally

What you will be doing:

Clinical Trial Monitoring

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan and applicable prevailing laws, Good Clinical Practices
• Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
• During study conduct, serve as the primary point of contact for assigned investigator sites. Work in partnership with and/or escalate to the SCP to ensure quality of site delivery

• Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
• Partner with SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks
• Attend investigator meeting when required (virtual or F2F) Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with SCP and the study team to define and support recruitment initiatives at site level
• Conduct remote assessment of a diary data
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities and ensure these are conducted accordance to the Study Monitoring Plan, SOPs and commensurate with emerging issues and technologies.
• Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution

• Submit all required reports, documentation, updates and tracking within required timeframes, including but not limited to Trial Master File documentation, site reports, site follow up letters, protocol deviations, patient recruitment, clinical supply management, study progress and metrics
• Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
• Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
• Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities.
• Support database release as needed
• May undertake the responsibilities of an unblinded monitor where appropriate

 Clinical/Scientific and Site Monitoring Risk:

• Maintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team
• Interact with investigator site heath care professionals in a manner which enhances Pfizer’s credibility, scientific leadership and in order to facilitate Pfizer’s clinical development goals
• Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
• Drive Quality Event remediation, when applicable
• Serve as a point of contact for audit conduct, and drive Audit Observation CAPA development and checks, when applicable

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You are:

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
• Knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations
• Monitoring Experience: At least +2 yrs relevant experience in clinical research site monitoring  and management
• Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
• Global clinical trial experience -Must
• Must be fluent in English and in the native language(s) of the country they will work in

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 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, inclusion & belonging are fundamental to our culture and values. 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, colour, 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.