Senior Clinical Research Associate - CNS/Oncology
W
Worldwide Clinical TrialsClinical research
This is a home-based Clinical Research Associate role supporting sites across the United Kingdom. Candidates must reside within the territoryFull-TimeSenior
Salary not disclosed
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Job Details
- Languages
- Proficiency in spoken and written English
- Experience
- At least 3 years of CRA experience with an MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent); at least 5 years with a four-year degree in a related science; or at least 7 years with a two-year college curriculum or equivalent education/training.
- Required Skills
- Microsoft Office
Requirements
- Have an MD or Pharmacy degree (MSPH, PharmD, PhD, or equivalent) and at least 3 years of CRA experience; or
- Have a four-year degree in medical, biological, physical, health, pharmacy, or another related science and at least 5 years of CRA experience; or
- Have a two-year college curriculum or equivalent education/training, preferably nursing or life sciences, and at least 7 years of CRA experience.
- Have extensive knowledge of clinical research principles and processes, GCP, SOPs, FDA and/or EU regulations and directives, ICH Guidelines, and applicable local regulatory requirements.
- Bring expertise across two to three therapeutic areas, sufficient to operate as a Lead CRA where appropriate.
- Demonstrate leadership, communication, mentoring, problem-solving, prioritization, and site-team guidance skills.
- Be proficient with Microsoft Office, IxRS, and EDC systems.
- Have a valid current passport and driving licence.
- Be proficient in spoken and written English.
- Full-service monitoring experience is preferred.
Responsibilities
- Lead site qualification, initiation, interim monitoring, management, and close-out in accordance with protocols, GCP, regulations, and SOPs.
- Review informed consent, safety information, source documentation, CRFs, and protocol compliance to protect patient safety and data quality.
- Work with investigators and site teams to resolve data queries and maintain regulatory and ethical documentation.
- Support the Investigator Site File and provide required documentation for the Trial Master File.
- Coordinate CRAs as a Lead CRA on global studies and work with Project Management to evaluate milestones and deliverables.
- Mentor less experienced CRAs and site staff through accompanied visits, monitoring report feedback, and study-specific training.
- Develop monitoring plans, tools, and templates, and coordinate shipment and receipt of study materials.
- Ensure appropriate investigational product receipt, accountability, return, or destruction at assigned sites.
- Contribute clinical monitoring expertise to study team and investigator meetings, bid defenses, protocols, and CRFs.
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