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Clinical Research Associate

Roles & Responsibilities

  • Bachelor’s degree in Life Sciences or equivalent, or qualified RN
  • 2+ years of on-site monitoring experience in pharmaceutical or CRO environments
  • Experience monitoring oncology trials
  • Proficient in ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF

Requirements:

  • Serve as the primary point of contact between investigational sites and sponsor for Oncology TA
  • Conduct site visits including site selection, initiation, routine monitoring, and close-out
  • Maintain up-to-date documentation in CTMS and eTMF systems and ensure data quality
  • Monitor patient safety with timely AE/SAE/PQC reporting and escalate risks to the clinical team

Job description

What You Will Be Doing:

  • Serve as the primary point of contact between investigational sites and the sponsor - Oncology TA

  • 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 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry

  • Experienced monitoring oncology trials required.

  • 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 southeast region; preference given to candidates residing in Los Angeles, CA near major HUB airports to support efficient regional travel

Are you a current ICON Employee? Please click here to apply: link

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