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Clinical Research Associate II/Sr. Clinical Research Associate - Oncology

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Parexel

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Location:
United States

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

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Job Description:

As a Clinical Research Associate (CRA) at Parexel, you act as an integral part to get treatments to patients sooner. Our CRAs' priority is the safety and well-being of the patients. As you travel to investigator sites and perform your monitoring duties, we encourage you to be inquisitive, take accountability, build relationships, and act with integrity. Join a team with a wide variety of experiences and knowledge, and work on global projects within a broad scope of therapeutic areas.

Job Responsibility:

  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality
  • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met
  • Serve as the primary point of contact for assigned investigator sites
  • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites
  • Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients
  • Provide protocol training to, and address protocol related questions from the investigator site staff when required
  • Attend investigator meeting when required (virtual or F2F)
  • Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
  • Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure activities
  • Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed
  • Submit all required reports, documentation, updates and tracking within required timeframes
  • Identify and resolve investigator site issues within required timeframes
  • Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelines
  • Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities
  • Support database release as needed
  • May undertake the responsibilities of an unblinded monitor where appropriate
  • Maintain thorough understanding of the product, protocol and therapy area
  • Interact with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership
  • Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators
  • Drive Quality Event (QE) remediation, when applicable
  • Serve as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable

Requirements:

  • Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulations
  • Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)
  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases
  • Must be fluent in English and in the native language(s) of the country they will work in
  • Ability to travel 60-80%
  • Valid driver’s license and passport required
  • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent
What we offer:
  • Flexible work arrangements
  • Career growth and development
  • Supportive and inclusive environment
  • Diverse therapeutic areas and project exposure
  • Advanced Technology

Additional Information:

Job Posted:
December 11, 2025

Work Type:
Remote work
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