Study Start Up CRA II

As a Study Start-Up Clinical Research Associate (SSU CRA) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This role focuses on the site selection, regulatory start-up, and activation phases of clinical trials. As an SSU CRA, you will collaborate with cross-functional teams, facilitate the seamless launch of clinical trial sites, and ensure compliance with regulatory and ethical standards. This role is ideal for professionals passionate about advancing clinical research while fostering partnerships with investigators and research sites.

What you will be doing:

• Collaborate with internal teams to identify, select, and activate clinical trial sites aligned with project timelines and requirements.
• Conduct Site Selection Visits (SSVs) to verify eligibility to participate in clinical studies for specific studies.
• Develop strong relationships with site personnel to ensure smooth site onboarding and activation.
• Prepare, submit, and manage IRB/IEC applications, regulatory filings, and other start-up documentation.
• Ensure that all activities comply with ICH-GCP guidelines, local regulatory frameworks, and internal Standard Operating Procedures (SOPs).
• Track and manage essential documents (e.g., regulatory approvals, contracts) to ensure timely site activation.
• Serve as the primary point of contact between sites, study teams, and external stakeholders throughout the start-up process.
• Collaborate closely with the SSU Manager to manage investigator contracts, payments, and site-specific start-up tasks.
• Provide regular status updates to internal and external stakeholders, ensuring alignment with key project milestones.
• Track, report, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.
• Proactively identify and resolve issues that could delay study start-up or impact trial deliverables.
• Maintain accurate documentation to facilitate audits and regulatory inspections.
• Support sites through the activation phase until they achieve “Green Light” status for study initiation.
• Coordinate with site staff to ensure all pre-study requirements are met, including contracts, budgets, and essential documentation.
• Assist in audit preparations to ensure compliance with regulatory and ethical standards.

You are:

• Bachelor’s degree in life sciences, nursing, or a related field

• Proficiency in English and the local language(s) of assigned sites

• At least 2 years of experience with Site Selection Visits and Study Start Up activities in clinical research, clinical operations, or site management at a CRO or Pharmaceutical company is preferred.

• Experience with Informed Consent Forms (ICF) review is desired.

• Strong organizational skills with a focus on timelines and deliverables is required.

• Ability to communicate effectively with cross-functional teams, investigators, and external stakeholders.

• Knowledge of ICH-GCP guidelines and local regulatory requirements is highly desirable.

• Responsible for meeting start-up timelines and achieving patient enrollment goals.

Pay Range ($89,376/year  – $111,720/year)

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.

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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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, color, 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.