Senior Clinical Research Associate

🕒 August 5

🇰🇷 South Korea – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 11%

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 assigned investigator sites from site initiation through database lock, including site management, monitoring, and close-out activities • Ensure clinical trials follow the Study Monitoring Plan, applicable laws, Good Clinical Practices, and Pfizer standards • Serve as the primary contact for assigned investigator sites and facilitate information flow among sites, vendors, and study-team members • Coach and train site personnel on protocols, compliance, patient safety, and operational or clinical trial risks • Support site activation, patient enrollment, recruitment initiatives, monitoring, and study-site closure • Conduct onsite and remote/electronic monitoring as needed • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit to resolve required information • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply information, study progress, and metrics • Identify and resolve site issues, develop corrective and preventative actions, and resolve data queries • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support database release and serve as an unblinded monitor when required • Maintain product, protocol, therapy-area, regulatory, and clinical research knowledge to support site discussions and patient safety • Drive Quality Event remediation and support audit observation CAPA development and checks when applicable • Mentor and train Clinical Research Associates and serve as an SME for CRA-related processes • Participate in regional or local working groups and process-improvement initiatives • Perform feasibility, site selection, site activation, ICD finalization, SIV, issue management, and co-monitoring activities as requested • Partner with Site Care Partners, Country SOM, study-team members, and other functional lines • Report to the Director of Clinical Site Operations, Director of Site Management and Monitoring, or Site Care Partner III in some countries

🎯 Requirements

• Bachelor’s degree in life sciences or professional degree in life sciences, such as nursing, pharmacy, or medical background, or equivalent • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations • Minimum 3 years of relevant clinical research site-monitoring experience, preferably including 2 years in Oncology • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases • Global clinical trial experience • Fluency in English and the native language(s) of the country of work • Advanced knowledge of clinical research and development processes • Demonstrated knowledge of global and local regulatory requirements • Advanced understanding of clinical research operations, including monitoring, data acquisition and cleaning, and reporting • Advanced disease and technical knowledge relevant to clinical studies, investigational products, and development plans • Ability to support sponsor regulatory interactions and inspections • Knowledge of protocol design and feasibility assessment • Understanding of regional/country culture and medical practice and their effects on clinical-trial delivery • Ability to work effectively 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 • Willingness and ability to travel significantly, 60–80% within the area, with possible international and weekend travel • Valid driver’s license and passport required