Senior Clinical Research Associate

🔥 2 hours ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH Good Clinical Practice (GCP) guidelines. • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites. • Performs site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget and contract negotiations. • Reviews and verifies accuracy of clinical trial data collected onsite or remotely. • Provides regular site status information to team members and trial management and updates trial management tools. • Completes monitoring activity documents as required by sponsor SOPs. • Works with clinical team members to resolve trial and clinical issues. • Escalates site and trial-related issues until resolved or closed. • Performs essential document site file reconciliation, source document verification, and query resolution. • Assesses investigational product accountability, dispensation, and compliance. • Verifies serious adverse event reporting according to trial specifications and ICH GCP guidelines. • Communicates with investigative sites and updates applicable tracking systems. • Ensures required training is completed and documented. • Functions with little oversight at the senior level and may serve as a subject matter expert. • May be assigned complex studies and/or sites. • Provides leadership to assigned clinical operations projects. • Serves as observation and performance visit leader. • Interacts with other functional areas to resolve site issues and facilitate trial timelines.

🎯 Requirements

• An undergraduate degree or it’s equivalent in clinical, science, or health related field from an accredited institution; a licensed health care professional (i.e. registered nurse) or equivalent work experience required. • 2-5 years clinical monitoring experience required (CRA 2) • 5+ years clinical monitoring experience required (Sr CRA) • Knowledge of ICH and local regulatory authority regulations regarding drug • Read, write and speak fluent English. • Oncology monitoring experience required • Experience doing feasibility/site selection/site start up required. • Budget negotiations experience preferred. • 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.

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways