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Senior Clinical Research Associate - Oncology - New York ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a valu…
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Philadelphia, Pennsylvania, United States · On-site
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Philadelphia, Pennsylvania, United States · On-site
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Philadelphia, Pennsylvania, United States · Hybrid
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Philadelphia, Pennsylvania, United States · On-site
About us: Our purpose at Dispatch is to help create a world where all cancer patients can be cured. We’re humbled by the opportunity to work together as a team on some of the most pressing medical challenges of our time.…
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New York, New York, United States · On-site
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Philadelphia, Pennsylvania, United States · Hybrid
Position Title: Sr. Specialist, Quality Documents Location: Hybrid/Philadelphia, PA Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company focused on developing and launching curative targeted cell t…
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Philadelphia, Pennsylvania, United States · Hybrid
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Arcadis is the world's leading company delivering sustainable design, engineering, and consultancy solutions for natural and built assets. We are more than 34,000 people, in over 30 countries, dedicated to improving qual…
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ALL4Philadelphia, Pennsylvania, United States · Hybrid
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Philadelphia, Pennsylvania, United States · On-site
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapy for people with cancer. We are pioneering a transformational approach to treating …
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San Francisco, California, United States · On-site
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Children's Hospital of Philadelphia Research InstitutePhiladelphia, Pennsylvania, United States · On-site
$56/hr–$75/hr
SHIFT: Day (United States of America) Seeking Breakthrough Makers Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspi…
Skills: Pharmacy services, Home infusion, Clinical monitoring, USP 797 guidelines, Patient documentation
Philadelphia, Pennsylvania, United States · On-site
$44k–$55k/yr
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Philadelphia, Pennsylvania, United States · On-site
$118k–$156k/yr
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Skills: Patient assessment, Care planning, Diagnostic studies, Medication management, Endocrinology
Philadelphia, Pennsylvania, United States · On-site
$118k–$156k/yr
SHIFT: Any (United States of America) Seeking Breakthrough Makers Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspi…
Skills: Patient assessment, Care planning, Diagnostic studies, Clinical practice, Interdisciplinary collaboration
Philadelphia, Pennsylvania, United States · On-site
$107k–$142k/yr
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Skills: Clinical nursing, Vascular access, Patient care, Care coordination, Evidence-based practice
Philadelphia, Pennsylvania, United States · On-site
$67k–$77k/yr
University Overview The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks amo…
Skills: CAR T Cell Manufacturing, Flow Cytometry, ELISA, In Vitro Assays, In Vivo Mouse Studies
Philadelphia, Pennsylvania, United States · On-site
$84k–$107k/yr
SHIFT: Day (United States of America) Seeking Breakthrough Makers Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspi…
Skills: Clinical research coordination, Nursing, Neuro-oncology, Neurofibromatosis, Informed consent
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Perform comprehensive site management and monitoring activities for oncology clinical trials to ensure data integrity and subject safety. Act as the primary liaison between the client's trial team and sites while maintaining inspection readiness and compliance with protocols.
Requires a bachelor's degree and over 5 years of independent clinical trial monitoring experience, including at least 2 years in solid tumor trials. Candidates must be proficient in GxPs and willing to travel up to 50%.
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
Responsibilities:
Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites
Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials
May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
Promptly document monitoring activities and submit/approve visit reports
Manage site essential document collection and TMF reconciliation with site files
Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
Support sites and the client's regulatory inspections
Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
Lead site engagement initiatives and foster relationships with key Oncology sites and networks
Qualifications
Bachelor’s degree (scientific field preferred)
5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials.
1+ years early development trial experience
Solid tumor clinical trial experience is required
Experience utilizing Veeva systems is highly preferred
Demonstrated experience developing/maintaining site relationships and securing compliance
Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
Experience collaborating with sites from initial engagement through close-out phases
Experience activating sites
Experience training site staff
Experience supporting sites and/or sponsors in regulatory inspections
Experience working within a Functional Services (or in-house) monitoring model is preferred
Willing to travel up to 50%
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
ICON 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.
Salary Range
$110,520.00-$138,150.00Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
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