Senior Clinical Research Associate II

🕒 September 11

🇵🇱 Poland – Remote

💵 zł217.5k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 24%

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 and close-out • Ensure clinical trials follow the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards • Serve as primary contact for assigned investigator sites during study conduct • Partner with and escalate to the Site Care Partner to ensure quality site delivery • Facilitate information flow among study-team members, vendors and investigator sites • Develop, coach and train site personnel on protocol compliance and patient safeguarding • Attend investigator meetings when required, virtually or face-to-face • Support enrollment and resolve site activation and recruitment issues • Conduct onsite and remote/electronic monitoring for initiation, routine monitoring and closure • Monitor site-level adverse events and serious adverse events and follow up with investigator sites • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supply, progress and metrics documentation • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and prepare and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release • Undertake unblinded monitor responsibilities when required • Maintain product, protocol and therapy-area knowledge • Interact with healthcare professionals to support Pfizer’s clinical development goals • Support the study clinician with patient safety, eligibility and clinical guidance • Drive Quality Event remediation and support audits and CAPA activities • Mentor and train CRAs and Senior CRAs I • Serve as an SME for CRA-related processes • Participate in or lead global, regional or local working groups and process-improvement initiatives • Perform Site Care Partner duties for small projects or under guidance on larger projects • Conduct co-monitoring activities

🎯 Requirements

• Experience and capability to perform site management, site monitoring and close-out of assigned clinical trial investigator sites • Knowledge of applicable prevailing laws, Good Clinical Practices, Pfizer standards, study monitoring plans and SOPs • Ability to manage investigator site relationships and clinical trial delivery • Ability to resolve protocol-related issues and data queries within required timelines • Ability to conduct onsite and remote/electronic monitoring • Understanding of products, protocols and therapy areas sufficient for investigator and site-team discussions • Ability to monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Ability to manage investigational products, including receipt, handling, accounting, storage and destruction • Ability to support database release • Ability to perform unblinded monitor responsibilities when required • Ability to support patient safety, eligibility and clinical guidance • Ability to drive Quality Event remediation and Audit Observation CAPA development and checks • Ability to mentor/train Clinical Research Associates and Senior Clinical Research Associates I • Ability to serve as an SME for CRA-related processes • Ability to participate in or lead working groups and process-improvement initiatives • Ability to perform Site Care Partner duties for small projects or under guidance on larger projects • Ability to conduct co-monitoring activities • Work authorization/residence in Poland implied by the Poland-specific posting location

🏖️ Benefits

• Annual bonus: 15% • Medicover • Multisport • Life insurance • Private pension plan • Other corporate benefits as per Pfizer Pay Policy • Flexible workplace culture supporting work-life harmony • Reasonable adjustments for disability inclusion