Clinical Research Associate II

ICON; São Paulo; Híbrido; BRL 50.000 - 90.000; Tempo integral

Resumo da oferta

Join an established industry player in clinical research as a Clinical Research Associate, where you'll be at the forefront of advancing healthcare. In this dynamic role, you will manage site relationships, ensuring compliance and quality throughout all trial phases. You will work closely with a diverse team, leveraging your expertise in site monitoring and documentation practices. This position offers a competitive salary and an array of benefits focused on your well-being and work-life balance. If you're passionate about making a difference in the biopharmaceutical field, this is the opportunity for you.

Serviços

Health Insurance

Retirement Planning

Life Insurance

Gym Discounts

Childcare Vouchers

Travel Passes

Global Employee Assistance Programme

Qualificações

• 2+ years of site monitoring experience in bio/pharma/CRO settings.
• Strong knowledge of Good Documentation Practices and site management.

Responsabilidades

• Developing strong site relationships and ensuring compliance throughout trial phases.
• Conducting remote and on-site monitoring and oversight activities.

Conhecimentos

Site Monitoring

Good Documentation Practices

Data Analysis

Solution-oriented Problem Solving

Patient Recruitment Management

IT Skills

Formação académica

B.A./B.S. in Science or Biology

Ferramentas

CTMS

eTMF

Descrição da oferta de emprego

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

ICON Romania is currently looking to recruit experienced CRAs and Senior CRAs to join our FSP team. This is a sponsor-dedicated role that requires occasional work at the sponsor's offices in Bucharest—typically 1 day per week, but it could be less depending on monitoring visits. You will be part of a global biopharmaceutical company specializing in Oncology, Vaccines, Infectious Diseases, Neuroscience, and Cardiovascular diseases.

What you will be doing:

• Developing strong site relationships and ensuring continuity through all trial phases.
• Performing clinical study site management and monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan, and related documents.
• Participating in and providing input on site selection and validation activities.
• Conducting remote and on-site monitoring and oversight activities.
• Visiting sites for validation, initiation, monitoring, and close-out visits; documenting all contacts accurately and promptly.
• Collecting, reviewing, and monitoring regulatory documentation for study start-up, maintenance, and close-out.
• Communicating with Investigators and site staff regarding protocol conduct, recruitment, retention, deviations, documentation, audits/inspections, and performance.
• Identifying, assessing, and resolving site performance, quality, or compliance issues.
• Collaborating with various internal and external stakeholders, including vendors, IRBs/IECs, and regulatory authorities.
• Managing documentation in CTMS, eTMF, and other systems according to timelines.
• Sharing expertise and best practices within the CRA team, mentoring, and supporting audits/inspections.
• Performing co-monitoring visits as appropriate.

Requirements:

• B.A./B.S. in science and/or biology preferred.
• At least 2 years of site monitoring experience in bio/pharma/CRO settings.
• Experience in oncology trials is advantageous.
• Strong knowledge of Good Documentation Practices.
• Proven skills in site management, including performance and patient recruitment management.
• Good IT skills.
• Ability to analyze data/metrics and act accordingly.
• Solution-oriented with the ability to manage complex issues.
• Experience in root cause analysis and implementing corrective actions.

What ICON can offer you:

We prioritize building a diverse culture that rewards high performance and nurtures talent. Alongside a competitive salary, ICON offers various benefits focused on well-being and work-life balance, including:

• Various annual leave entitlements.
• Health insurance options for you and your family.
• Retirement planning options.
• Global Employee Assistance Programme, TELUS Health, providing 24/7 support from professionals.
• Life insurance.
• Optional benefits like childcare vouchers, bike schemes, gym discounts, travel passes, health assessments, and more.

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

At ICON, inclusion & belonging are core to our culture. We are committed to providing an accessible environment and a workplace free of discrimination and harassment. Qualified applicants will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. If you require a reasonable accommodation during the application process or to perform essential job functions, please let us know via the provided link.

https://careers.iconplc.com/reasonable-accommodations

We encourage you to apply even if you don’t meet all the requirements; you might be exactly who we’re looking for.

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