Clinical Research Associate - Oncology Early Development - Central / Southeast (Field Based)

ICON; Brasil; Teletrabalho; USD 30.000 - 50.000; Tempo integral

Resumo da oferta

ICON, a leading clinical research organization, is seeking a Clinical Research Associate (CRA) to work on oncology early development trials. The role involves mentoring junior team members, ensuring quality oversight, and collaborating with various stakeholders. Candidates should have a B.Sc. in Biological Sciences and relevant experience in clinical trials. ICON offers a diverse culture, competitive benefits, and opportunities for professional growth.

Serviços

Various annual leave entitlements

Health insurance options

Retirement planning options

Global Employee Assistance Programme

Life assurance

Flexible benefits such as childcare vouchers

Qualificações

• 1.5 to 2 years’ experience in monitoring pharmaceutical clinical trials.
• 1-3 years’ experience in oncology early development trials.
• In-depth knowledge of GCP, ICH guidelines, and local regulations.

Responsabilidades

• Work on multiple oncology early development trials.
• Mentor and coach junior team members.
• Monitor metrics and KPIs as outlined in the Quality Oversight Plan.

Conhecimentos

Strong communication

Influencing skills

Collaboration

Formação académica

B.Sc. in Biological Sciences

Ferramentas

CTMS

EDC

eTMF

IWRS

Descrição da oferta de emprego

As a CRA, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

What will you be doing?

• Work on multiple oncology early development trials
• Focus on quality of life with regional travel
• Demonstrate leadership through involvement in initiatives and act as SME for systems and processes
• Mentor and coach junior team members
• Develop site start-up documents, including SIV agenda
• Review study documents, such as Monitoring Guidelines, providing the SM “voice”
• Represent LTMs or SMs in meetings
• Take over LTM report reviews (SQV, SMV, SCV) for sites assigned to other SMs within the same trial
• Support country budget development and contract negotiations with CCS colleagues
• Assist with ASV processes
• Monitor metrics and KPIs as outlined in the Quality Oversight Plan (QOP)

Interfaces – Primary and Other:

• Primary: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, Central Study Team
• Others: Study Physician, Regional Quality & Compliance, Local Drug Safety Officer, Site Manager team, Investigators, and site personnel

Qualifications Needed:

• Located near a major airport in the Central US region
• Minimum of a B.Sc., R.N., or equivalent in Biological Sciences
• 1.5 to 2 years’ experience in monitoring pharmaceutical clinical trials
• 1-3 years’ experience in oncology early development trials, including Phase I and II
• Experience with analytical/risk-based monitoring is a plus
• Ability to drive patient recruitment strategies and collaborate with investigators and site staff
• Proficiency with systems like CTMS, EDC, eTMF, IWRS, and safety reporting
• Strong communication, influencing skills, and ability to work independently and in teams
• In-depth knowledge of GCP, ICH guidelines, and local regulations
• Willingness to travel up to 40%
• Legally authorized to work in the US without future sponsorship requirements

What ICON can offer you:

We prioritize building a diverse culture that rewards high performance and nurtures talent. Our benefits include:

• Various annual leave entitlements
• Health insurance options
• Retirement planning options
• Global Employee Assistance Programme (TELUS Health)
• Life assurance
• Flexible benefits such as childcare vouchers, gym discounts, travel passes, and health assessments

Visit our careers website to learn more: https://careers.iconplc.com/benefits

ICON is committed to inclusion and providing an accessible environment. For accommodations, contact us at: https://careers.iconplc.com/reasonable-accommodations

We encourage you to apply even if you do not meet all requirements; you might be the perfect fit for this or other roles at ICON.