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Global drug and device development services

Senior Clinical Research Associate

Clinical Research OperationsConfirmed live in the last 24 hours
Full-time

About the Job

Requirements

  • A Bachelor's degree in Life Sciences or equivalent, or qualification as a registered nurse.
  • Eligibility to work in the United States without visa sponsorship.
  • At least 3 years of on-site monitoring experience in the pharmaceutical or contract research organization industry.
  • Experience monitoring oncology trials, including prostate cancer or lung cancer, and/or hematology oncology trials.
  • Proficiency in ICH-GCP, local regulatory requirements, and clinical systems such as CTMS and eTMF.
  • Willingness and ability to travel up to 50% for on-site monitoring visits across the southeast region.

Responsibilities

  • Serve as the primary point of contact between investigational sites and the sponsor.
  • Conduct site visits, including selection, initiation, routine monitoring, and close-out.
  • Ensure site compliance with ICH-GCP, standard operating procedures, and regulations.
  • Maintain current documentation in CTMS and eTMF systems.
  • Support and track site staff training and maintain compliance records.
  • Monitor patient safety and ensure timely and accurate adverse event, serious adverse event, and product quality complaint 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 clinical trial assistants, lead trial managers, and clinical trial managers.

Desired Qualifications

  • Preference is given to candidates residing in Tennessee or Kentucky near major hub airports to support efficient regional travel.

About the Company

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Global drug and device development services

This company provides consulting, development, and commercialization support for drugs and medical devices through a global network of offices. Its team across 53 countries offers end-to-end services, from strategy and regulatory work to manufacturing and market access, helping clients shorten development time, lower costs, and raise quality. It differentiates itself with wide geographic reach and a clear focus on reducing time to market and cost while leveraging deep experience across many therapeutic areas. Its goal is to help clients accelerate the development of life-saving products and improve quality of life by delivering reliable information, practical solutions, and solid performance.

Company size
10,001+
Company stage
IPO
Headquarters
Ireland
Founded
1990

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