Senior Clinical Research Associate

🕒 July 28

🇬🇧 United Kingdom – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🇬🇧 UK Skilled Worker Visa Sponsor

This company has sponsored UK Skilled Worker visas in the past.

👻 Ghost score 28%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 Description

• Manage and monitor assigned investigator sites from site activation through database lock and closeout • Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, Good Clinical Practices, and Pfizer standards • Serve as the primary point of contact for assigned investigator sites during study conduct • Partner with the Site Care Partner and study team to ensure quality site delivery • Facilitate information flow among study team members, vendors, and investigator sites • Develop, coach, and train site personnel on protocols and ongoing compliance • Address protocol-related questions and discuss operational and clinical trial risks • Attend investigator meetings and support enrollment, site activation, recruitment initiatives, and recruitment issue resolution • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure • Monitor site-level AEs and SAEs and collaborate with the Drug Safety Unit on resolution • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply information, study progress, and metrics • Identify and resolve investigator site issues and develop corrective and preventative actions • Resolve data queries and prepare and conduct investigator site closeout activities • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support database release as needed • Undertake unblinded monitor responsibilities where appropriate • Maintain product, protocol, and therapy-area knowledge for investigator discussions • Support patient safety, eligibility, and clinical guidance with the study clinician • Drive Quality Event remediation and Audit Observation CAPA activities when applicable • Mentor/train Clinical Research Associates and Senior Clinical Research Associates I as assigned • Serve as a subject matter expert on related initiatives or planning

🎯 Requirements

• Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Minimum 3 years relevant experience in clinical research site monitoring • Some experience in Oncology • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Global clinical trial experience • Must be fluent in English and in the native language(s) of the country they will work in • Demonstrated knowledge of clinical research and development processes • Demonstrated knowledge of global and local regulatory requirements • Demonstrated understanding of monitoring, data acquisition and cleaning, reporting, and related operational elements • Demonstrated knowledge in disease and technical areas pertaining to clinical studies • Demonstrated ability to support sponsor regulatory interactions/inspections • Demonstrated knowledge of protocol design and feasibility assessment processes • Demonstrated understanding of region/country, culture, and medical practice and their effect on clinical trial delivery • Proven ability to work in a matrix team environment and influence, drive/lead, and work through others • Ability to evaluate, interpret and present complex issues and data for risk management and mitigation • Effective verbal and written communication skills • Valid passport and driver’s license

🏖️ Benefits

• Flexible workplace culture supporting work-life harmony • Reasonable adjustments to support applicants and future careers • Significant travel opportunities within the area, with some international and weekend travel