Clinical Research Associate - SOAR

Clinical Research Associate (Start-Up) - Oncology - USAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise. As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.What will you be doing?Works on multiple trials within the Cross Therapeutic areas - Start up focusCollaborate with country operations teams to identify, select, and activate clinical trial sites in accordance with project timelines and requirements.Perform Site Qualification Visits (SQVs) to assess the eligibility of sites for participation in specific clinical studies.Build strong relationships with site personnel to facilitate a smooth onboarding process.Ensure that all activities adhere to ICH-GCP guidelines, local regulatory standards, and internal Standard Operating Procedures (SOPs).Coordinate with the country operations team to collect essential documents (such as regulatory approvals and contracts) to enable timely site activation.Act as the main point of contact for sites, study teams, and external stakeholders throughout the start-up process.Work closely with the country operations team to manage investigator contracts, regulatory documents, and site-specific start-up activities.Provide regular status updates to both internal and external stakeholders, ensuring alignment with important project milestones.Monitor, report on, and analyze key performance indicators (KPIs) related to site selection and start-up timelines.Proactively identify and address any issues that may delay study initiation or affect trial deliverables.Maintain precise documentation to ensure readiness for inspections.Support sites during the activation phase until they achieve "Green Light" status for site opening.Facilitate coordination with site staff to ensure all pre-study requirements, including contracts, budgets, and essential documentation, are met.Possibly assist in audit and inspection preparations to guarantee compliance with regulatory and ethical standards.What do you need to have?Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological SciencesPreferred location is near a major airport.Must have 2 -3 years' experience in monitoring pharmaceutical industry clinical trialsHave a minimum of 1-3 years' experience monitoring oncology clinical trialsStudy Start up experience requiredAnalytical/risk-based monitoring experience is an assetAbility to actively drive patient recruitment strategies at assigned sitesAbility to partner closely with investigator and site staff to meet all of our study timelinesAbility to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently.Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.Employment with ICON is contingent upon having the legal right to work in the country where the role is based.Rewards & BenefitsICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.Benefits may include:Competitive base salary and performance related incentivesHealth and wellbeing programmes including medical, dental, and vision coverage where applicableRetirement and pension plansLife assurance and disability coverageEmployee assistance programmes and wellbeing resourcesLearning and development opportunities through structured training and career pathwaysBenefits may vary depending on role and location.Visit our careers site to read more about the benefits ICON offers.Inclusion and AccessibilityICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.