Unblinded CRA II

Pharmaceutical Research Associates, Inc; Palma de Mallorca; Presencial; EUR 30.000 - 50.000; Jornada completa

Descripción de la vacante

A leading clinical research organization is seeking an Unblinded CRA to monitor clinical trial sites and ensure compliance with GCP/ICH guidelines. The successful candidate will build strong relationships with investigators and coordinate closely with study teams. This role requires a proactive approach to site management and a solid background in healthcare or clinical research, particularly in oncology.

Servicios

Various annual leave entitlements

Health insurance options

Retirement planning offerings

Global Employee Assistance Programme

Flexible benefits including childcare vouchers

Formación

• 2-4 years of relevant healthcare experience in the pharma or clinical research industry.
• Minimum 2 years of monitoring and site management experience.
• Fluent in English, both written and oral.

Responsabilidades

• Monitor multiple Phase I, II, III & IV clinical trial sites.
• Provide key project updates and collaborate with site staff.
• Ensure adherence to GCP / ICH practices.

Conocimientos

Attention to detail

Customer service mindset

Proficiency with medical terminology

Strong communication

Technical skills with CTMS, eCRF, eTMF

Educación

Bachelor’s Degree

Descripción del empleo

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

Responsibilities

What you will be doing :

• You will monitor multiple Phase I, II, III & IV clinical trial sites (Pharmacy visits).
• You will utilise your customer service mindset with your sites focusing on delivering value, building loyalty and trust to create a positive impact and strong relationship with investigators and study coordinators where respect, knowledge and commitment to ICH / GCP guidelines are key to successful trial conduct.
• As the CRA you are the main sponsor representative, providing key project updates. You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely.
• As the first point of contact for study sites, escalating any concerns / issues to other departments including Safety, Investigational Medicinal Product, Local Study Managers and management team as appropriate.
• Additionally, you will oversee the sites' adherence to GCP / ICH practices, ensuring quality of study conduct.

Qualifications

You are :

• Bachelor’s Degree (or equivalent) with 2-4 years of relevant healthcare experience in the pharma or clinical research industry. Minimum 2 years of monitoring and site management experience.
• Strong experience in Oncology and in Pharmacy visits.
• Experience in Phase I trials is a plus.
• Scientific background.
• Proficiency with medical terminology.
• Working knowledge of Local Regulations.
• A demonstrated working knowledge of ICH / GCP Guidelines.
• Excellent record-keeping skills and attention to detail.
• Experience conducting Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site.
• Fluent in English, both written and oral.
• Strong technical skills with CTMS, eCRF, eTMF.

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.

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.

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