Clinical Research Associate (CRA II)

As a Clinical Research Associate II you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

ICON Romania are currently looking to recruit an experienced CRA II to join our FSP team. This is a sponsor dedicated role.You wil be a part of a global biopharmaceutical company that are the leader in cell and gene therapy (CGT)  and are also specialised in cardiology, hematology, oncology, endocrinology, etc. 

What you will be doing:

• • Performs on-site monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  • Participates & provides inputs on site selection and validation activities.
  • Performs remote and on-site monitoring & oversight activities
  • Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
  • Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
  • Identifies, assesses and resolves site performance, quality or compliance problems
  • Manages and maintains information and documentation in CTMS, eTMF and various other systems as appropriate and per timelines.
  • Contributes to CRA team knowledge by acting as process Subject Matter Expert (SME), buddy/mentor and sharing best practices as appropriate/required.
  • Supports and/or leads audit/inspection activities as needed.
  • Performs co-monitoring visits where appropriate

Requirements:

• university degree
• 2-3 years of direct on-site monitoring experience in a bio/pharma/CRO
• Proven Skills in Site Management including management of site performance and patient recruitment
• Good IT skills
• Ability to understand and analyze data/metrics and act appropriately
• Capable of managing complex issues, works in a solution-oriented manner.

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.

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