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










