Clinical Research Associate (SOAR) - Multi TA

Icon - Lenexa, KS

Full-time - Mid Level

Lenexa, KS

Professional, Scientific, and Technical Services

About the position

As a Clinical Research Associate (CRA) at ICON Clinical Research, you will play a crucial role in managing multiple clinical trials across various therapeutic areas, focusing on the start-up phase. Your responsibilities will include collaborating with country operations teams to activate clinical trial sites, ensuring compliance with regulatory standards, and maintaining strong relationships with site personnel to facilitate smooth onboarding processes. You will be the main point of contact for sites and stakeholders, providing updates and addressing any issues that may arise during the study initiation process.

Responsibilities

• Work on multiple trials within Cross Therapeutic areas with a focus on start-up.
• Collaborate with country operations teams to identify, select, and activate clinical trial sites.
• Perform Site Qualification Visits (SQVs) to assess site eligibility for clinical studies.
• Build strong relationships with site personnel for smooth onboarding.
• Ensure adherence to ICH-GCP guidelines, local regulatory standards, and internal SOPs.
• Coordinate with the country operations team to collect essential documents for site activation.
• Act as the main point of contact for sites, study teams, and external stakeholders during the start-up process.
• Manage investigator contracts, regulatory documents, and site-specific start-up activities.
• Provide regular status updates to internal and external stakeholders.
• Monitor, report on, and analyze KPIs related to site selection and start-up timelines.
• Proactively identify and address issues that may delay study initiation.
• Maintain precise documentation for inspection readiness.
• Support sites during the activation phase until they achieve 'Green Light' status.
• Facilitate coordination with site staff to meet pre-study requirements.

Requirements

• Minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences.
• 2-3 years' experience in monitoring pharmaceutical industry clinical trials.
• Knowledge of several therapeutic areas.
• Analytical/risk-based monitoring experience is an asset.
• Ability to drive patient recruitment strategies at assigned sites.
• Ability to partner closely with investigator and site staff to meet study timelines.
• Ability to operate various systems and databases (e.g., CTMS, EDC, eTMF).
• Strong communication and influencing skills to manage study sites remotely and face to face.
• In-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements.
• Legally authorized to work in the United States without requiring sponsorship.

Nice-to-haves

• Experience in audit and inspection preparations.
• Familiarity with global clinical trial processes.

Benefits

• Various annual leave entitlements
• A range of health insurance offerings
• Competitive retirement planning offerings
• Global Employee Assistance Programme
• Life assurance
• Flexible country-specific optional benefits including childcare vouchers and discounted gym memberships