ICON plc

Senior Clinical Research Associate

ICON plc$95K — $115K *
US-Anywhere
+ 2 other locationsRemote
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor’s degree in scientific field preferred
  • 5+ years of independent clinical trial monitoring experience
  • At least 2 years monitoring solid tumor clinical trials
  • 1+ years in early development oncology trial or Phase III oncology trial
  • Experience with Veeva systems preferred
  • Strong expertise in GxPs and oncology monitoring techniques
  • Proven ability to build site relationships and ensure compliance

Responsibilities

  • Perform site management activities to enhance client Oncology site success
  • Act as primary contact facilitating communication between trial team and sites
  • Conduct remote and on-site monitoring visits to ensure data integrity and subject safety
  • Oversee activities to assess monitoring quality and mentor junior CRAs
  • Document monitoring activities and approve visit reports
  • Manage collection of essential documents and TMF reconciliation
  • Support site IRB/Ethics Committee submissions and confirm approvals
  • Analyze site Key Risk Indicator metrics for trends and prompt resolution
  • Determine root causes and implement Corrective Action and Preventive Action plans
  • Deliver training for compliance with protocols, SOPs, and GCPs
  • Support regulatory inspections at sites
  • Contribute to site identification and activation initiatives
  • Lead site engagement efforts and develop relationships with Oncology sites

Benefits

  • Collaborative team environment that emphasizes professional growth
  • Opportunities for mentorship and training in advanced oncology practices
  • Support for work-life balance with flexible work arrangements
  • Access to cutting-edge resources and technologies in clinical research
  • Commitment to improving patient outcomes through innovative trials
Full Job Description
Senior Clinical Research Associate - Oncology - Baltimore, MD or Phila, PA The Sr. Clinical Research Associate (Sr. CRA) will be responsible for performing investigative site management and monitoring activities throughout the clinical trial lifecycle. This Sr. CRA role will support the client's Oncology clinical trials to ensure data integrity, subject safety, and inspection readiness at the clinical investigative sites.  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 oncology trial experience and/or Phase III Oncology 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%

About ICON plc

ICON plc is a global provider of drug development and commercialisation services to the pharmaceutical, biotechnology and medical device industries. The company specialises in the strategic development, management and analysis of programs that support clinical development. ICON has approximately 15700 employees in 40 countries. The company was founded in Dublin, Ireland in 1990 and is headquartered in Leopardstown, Dublin. ICON has been publicly traded on the NASDAQ since 1998.
Learn more about ICON plc
Size
39,300 employees
Market Cap
$16.2 billion
Industry
Net Income
$332.3 million
Founded
2017
5 Year Trend
+26.9%
Revenue
$2.7 billion
NASDAQ

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