ICON plc

Clinical Research Associate, Multi TA

ICON plc

full-time

Posted on:

Location Type: Remote

Location: Texas • United States

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Tech Stack

Google Cloud Platform

About the role

  • Works on multiple trials within the Cross Therapeutic areas - Start up focus
  • Collaborate 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.

Requirements

  • Have a minimum of a B.S., R.N., or equivalent degree, preferably in Biological Sciences
  • Must be located in Texas, near a major airport.
  • Must have 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials
  • Have a minimum of 1-3 years' experience monitoring cross therapeutic area clinical trials
  • Knowledge of several therapeutic areas
  • Analytical/risk-based monitoring experience is an asset
  • Ability to actively drive patient recruitment strategies at assigned sites
  • Ability to partner closely with investigator and site staff to meet all of our study timelines
  • Ability 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.
Benefits
  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs.
  • Competitive retirement planning offerings to maximize 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical trial monitoringsite qualification visitsanalytical monitoringpatient recruitment strategiesGood Clinical PracticeICH guidelinesregulatory compliancerisk-based monitoringdocumentation managementperformance indicators analysis
Soft Skills
communication skillsinfluencing skillsteam collaborationindependenceproblem-solvingrelationship buildingorganizational skillsstakeholder managementadaptabilityattention to detail
Certifications
B.S. degreeR.N. degreeclinical trial certification