Senior CRA-Oncology-FSP Job at ICON Strategic Solutions, Michigan

WDZsdG9PaE9aRWtWeGhwSjR1RlFmS2FiS2c9PQ==
  • ICON Strategic Solutions
  • Michigan

Job Description

**6-8 DOS**

**Must have 4+ years of independent monitoring experience**

**Must have Veeva experience -CTMS- writing reports/follow up letters**

** Must have 3 + years of Oncology experience**

  • Perform site management activities to support Oncology site success and maintain a
  • Continuous state of inspection readiness
  • Act as the primary contact and facilitate efficient communications between the 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 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 during 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

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

  • Various annual leave entitlements
  • A range of health insurance offerings to suit you and your family’s needs
  • Competitive retirement planning offerings to maximise 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

Visit our careers website to read more about the benefits of working at ICON:

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

Job Tags

Interim role, Local area, Flexible hours,

Similar Jobs

Lowe's

Full Time - Sales Specialist - ProServices - Day Job at Lowe's

 ...for every Pro customer who walks through our doors. Every single day, Pro Customers are building, maintaining, repairing and operating...  ...Gain extra savings with a 10% Associate Discount. Learn new trade skills with our Track to the Trades program. For information... 

Kellymoss Inc.

Porsche Project Shop Technician Job at Kellymoss Inc.

 ...WI - Onsite About Kellymoss At Kellymoss, we don't just build Porscheswe engineer champions. As a global leader in Porsche motorsports, custom builds, and elite restoration, we combine precision, performance, and passion to push the limits of what's possible. With... 

Milevista

Marketing Associate - Entry Level Job at Milevista

 ...sales, one real connection at a time. Role Description This is a full-time on-site role for a Marketing Associate - Entry Level located in Culver City, CA. The Marketing Associate will be responsible for conducting market research, supporting sales initiatives... 

KPFF Consulting Engineers

Structural Engineering Project Manager Job at KPFF Consulting Engineers

Company Description At KPFF Consulting Engineers , we are more than just an engineering design firm . For over 60 years , we have dedicated ourselves to innovative, sustainable engineering that shapes the built environment and tackles complex infrastructure...

KODIAK Construction Recruiting & Staffing

Mechanical Construction Assistant 기계 건설 어시스턴트 (기계 또는 고순도 배관) Job at KODIAK Construction Recruiting & Staffing

 ...Mechanical Construction Assistant (Mechanical or High Purity Piping)- Austin, TX AREA ( ) Looking for an opportunity to grow your career on one of the most advanced high-tech construction projects in the U.S.? This role blends paperwork and...