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ICON plc
ICON plc
ConsultingHealthcareLogistics
ICON plc is a global contract research organisation serving the healthcare and pharmaceutical industries. Its work spans clinical, consulting, and commercial services that support drug development from early research through post-marketing activities. The company provides solutions including decentralised clinical trials, cardiac safety, early clinical laboratories, medical imaging, regulatory intelligence, and real-world evidence. ICON plc also brings therapeutic expertise to areas such as cardiovascular disease, oncology, internal medicine, cell and gene therapies, and biosimilars, combining data analysis with patient-focused approaches to help advance clinical programmes.
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Senior Clinical Research Associate, Oncology — ICON plc (Remote, Pennsylvania)

Senior Clinical Research Associate supporting sponsor-dedicated oncology trials for ICON plc. The role oversees site monitoring, regulatory compliance, data quality, and resolution of clinical trial issues.

USUnited StatesPAPennsylvaniaRemoteFull-timeSeniorEnglish RequiredClinical Research
Google Cloud Platform

Description

  • Conduct and monitor clinical trials to confirm sponsor and investigator responsibilities meet applicable regulations and ICH Good Clinical Practice (GCP) standards.
  • Evaluate prospective investigative sites, initiate studies, train site staff, and complete site closeout activities.
  • Manage site startup tasks, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations.
  • Review clinical trial data collected onsite or remotely and verify its accuracy.
  • Report site status to clinical team members and trial management, while maintaining trial management tools.
  • Complete monitoring documentation in accordance with sponsor standard operating procedures.
  • Collaborate with clinical team members to address trial and clinical issues.
  • Escalate site and trial concerns through resolution or formal closure.
  • Reconcile essential documents in site files, perform source document verification, and resolve data queries.
  • Evaluate investigational product accountability, dispensing, and compliance.
  • Verify serious adverse event reporting against trial requirements and ICH GCP guidelines.
  • Communicate with investigative sites and maintain relevant tracking systems.
  • Confirm that required training is completed and documented.
  • Work independently at the senior level and contribute subject matter expertise when appropriate.
  • Support complex studies and sites as assigned.
  • Lead designated clinical operations projects.
  • Serve as the leader for observation and performance visits.
  • Coordinate with other functional areas to resolve site issues and support trial timelines.

Requirements

  • Bachelor’s degree or equivalent in a clinical, scientific, or health-related discipline from an accredited institution; a licensed healthcare professional, such as a registered nurse, or equivalent work experience is also accepted.
  • Two to five years of clinical monitoring experience for CRA 2 roles.
  • More than five years of clinical monitoring experience for Senior CRA roles.
  • Understanding of ICH requirements and local regulatory authority regulations for drug studies.
  • Fluent written and spoken English.
  • Previous oncology monitoring experience.
  • Experience with feasibility assessments, site selection, and site startup.
  • Budget negotiation experience is preferred.
  • Applicants must be legally authorized to work in the United States and must not require current or future employment visa sponsorship.
  • Employment with ICON requires the legal right to work in the country where the role is based.

Benefits

  • Competitive base pay with performance-related incentives.
  • Health and wellbeing programs, including medical, dental, and vision coverage where applicable.
  • Retirement and pension plans.
  • Life insurance and disability coverage.
  • Employee assistance programs and wellbeing resources.
  • Structured training and career development opportunities.

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