Senior Clinical Research Associate

ICON Strategic Solutions

Pennsylvania

On-site

USD 95,000 - 135,000

Full time

14 days+
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Benefits offered by this job

Annual leave
Health insurance
retirement planning
Global EAP LifeWorks
Life assurance
Flexible country-specific benefits

Job summary

ICON is seeking a Senior Clinical Research Associate - Oncology (Myelofibrosis) for the East Region. The role acts as the primary liaison between investigative sites and the sponsor, leading on-site monitoring activities to ensure study integrity.

You will conduct site visits, ensure ICH-GCP compliance, and maintain CTMS/eTMF documentation. Travel up to 50% across the East region, with focus on data quality and patient safety throughout oncology trials.

Qualifications

  • 3+ years of on-site monitoring in pharma or CRO.
  • Experience in Oncology, specifically Myelofibrosis trials.
  • Proficient with ICH-GCP and local regulatory requirements.

Responsibilities

  • Serve as the primary point of contact between investigational sites and sponsor.
  • Conduct site visits including selection, initiation, routine monitoring, and close-out.
  • Ensure site compliance with ICH-GCP, SOPs and regulations.
  • Maintain CTMS and eTMF documentation and ensure accuracy.
  • Support site staff training and maintain compliance records.
  • Monitor patient safety and timely AE/SAE reporting.
  • Support subject recruitment and retention efforts at sites.
  • Oversee drug accountability and storage/destruction as required.
  • Drive high-quality data entry and resolve data queries.
  • Escalate risks or issues to the clinical team as needed.

Skills

On-site monitoring experience
Oncology trials
ICH-GCP compliance
Communication & collaboration
Travel readiness
US work authorization

Education

Bachelor's degree Life Sciences or RN

Tools

CTMS
eTMF

Job description

Senior Clinical Research Associate - Oncology (Myelofibrosis) - East Region

What You Will Be Doing
  • Serve as the primary point of contact between investigational sites and the sponsor
  • Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
  • Ensure site compliance with ICH‑GCP, SOPs, and regulations
  • Maintain up-to-date documentation in CTMS and eTMF systems
  • Support and track site staff training and maintain compliance records
  • Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
  • Support subject recruitment and retention efforts at the site level
  • Oversee drug accountability and ensure proper storage, return, or destruction
  • Resolve data queries and drive timely, high-quality data entry
  • Document site progress and escalate risks or issues to the clinical team
  • Assist in tracking site budgets and ensuring timely site payments (as applicable)
  • Collaborate with cross‑functional partners including CTAs, LTMs, and CTMs
You Are
  • A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
  • Eligible to work in United States without visa sponsorship
  • A clinical research professional with 3+ years of on‑site monitoring experience in the pharmaceutical or CRO industry
  • Experienced monitoring Oncology specifically Myelofibrosis clinical trials.
  • Proficient in ICH‑GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
  • A clear communicator, problem‑solver, and collaborative team player
  • Willing and able to travel up to 50% for on‑site monitoring visits across the East region; preference given to candidates residing near major HUB airport to support efficient regional travel
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 maximize savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, LifeWorks, offering 24‑hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.

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.

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