Senior Clinical Research Associate – Oncology

Posted 4hrs ago

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Job Description

Senior Clinical Research Associate monitoring UK oncology clinical-trial sites for global CRO Worldwide Clinical Trials. Leading site activities, CRA coordination, compliance, and study delivery.

Responsibilities:

  • Lead site activities across the study lifecycle, including feasibility, qualification, initiation, interim monitoring, site management, and close-out visits
  • Monitor protocol adherence, patient safety, informed consent, source documentation, study data, CRFs, and investigational product accountability
  • Resolve data queries with sites and maintain Investigator Site Files
  • Complete regulatory and ethics documentation and provide documentation for the Trial Master File
  • Coordinate CRAs as a Lead CRA on global studies and work with Project Management to evaluate study deliverables and milestones
  • Mentor less experienced CRAs and site staff through accompanied visits, training, and guidance
  • Review site visit reports and provide constructive feedback
  • Contribute to Clinical Monitoring Plans, protocols, CRFs, study-specific tools, templates, and monitoring/site-management process initiatives
  • Collaborate in study team meetings, investigator meetings, and bid defenses
  • Maintain regular communication with investigative sites, sponsors, and global study teams
  • Travel to investigative sites approximately 6–8 days per month

Requirements:

  • MD or Pharmacy degree with at least 3 years of CRA experience; or a four-year degree in medical, biological, physical, health, pharmacy, or related science with at least 5 years of CRA experience; or a two-year college curriculum or equivalent education/training, preferably nursing or life sciences, with at least 7 years of CRA experience
  • Thorough knowledge of clinical research principles and processes, GCP, ICH Guidelines, applicable FDA and/or EU regulations and directives, local regulatory requirements, and SOPs
  • Strong understanding of two to three therapeutic areas, with expertise required to operate as a Lead CRA where appropriate
  • Excellent planning, organization, time management, communication, interpersonal, problem-solving, leadership, and mentoring skills
  • Proficiency with Microsoft Office, IxRS, and EDC systems
  • Proficiency in spoken and written English, together with fluency in the local language(s) of the countries under responsibility
  • Valid current passport and driving license
  • Candidates must reside within the United Kingdom territory
  • Experience in full-service monitoring preferred

Benefits:

  • Collaborative and inclusive work environment
  • Growth and career development opportunities
  • Opportunity to learn, grow, and contribute to clinical research
  • Home-based work arrangement