Senior Clinical Research Associate I

🔥 15 hours ago

🇵🇱 Poland – Remote

💵 zł129.8k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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, monitor, and close out assigned investigator sites for clinical trials • Ensure clinical trials follow the Study Monitoring Plan, applicable laws, Good Clinical Practices, and Pfizer standards • Manage operational clinical trial activities from site initiation through database lock • Serve as primary contact for assigned investigator sites and coordinate with the Site Care Partner and study team • Facilitate information flow among study team members, vendors, and investigator sites • Coach and train site personnel on protocols, compliance, patient safety, and operational risks • Support enrollment and resolve site activation and recruitment issues • Conduct onsite and remote/electronic site initiation, routine monitoring, and site closure activities • Monitor site-level AEs and SAEs and collaborate with the Drug Safety Unit • Submit required Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management records, study progress, and metrics • Identify and resolve site issues and develop corrective and preventative actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product handling and accountability at investigator sites • Support database release and undertake unblinded monitor responsibilities when required • Support study clinicians with patient safety, eligibility, and clinical guidance • Drive Quality Event remediation and audit observation CAPA activities when applicable • Mentor/train Clinical Research Associates and participate in process improvement initiatives • Perform pre-activation activities including feasibility, site selection, PTA, activation checklist coordination, ICD finalization, and SIV • Conduct co-monitoring activities as requested

🎯 Requirements

• Experience and knowledge sufficient to manage investigator sites and monitor clinical trials • Knowledge of applicable prevailing laws, Good Clinical Practices, Pfizer standards, SOPs, and Study Monitoring Plans • Understanding of the product, protocol, and relevant therapy area • Ability to manage investigator site relationships and resolve protocol-related issues • Ability to monitor adverse events (AEs) and serious adverse events (SAEs) • Ability to manage clinical trial documentation, Trial Master File documentation, reports, tracking, and metrics • Ability to oversee investigational product receipt, handling, accounting, storage, and destruction • Ability to conduct onsite and remote/electronic monitoring • Ability to support patient safety, eligibility, recruitment, database release, and audit/CAPA activities • Ability to mentor/train Clinical Research Associates and serve as an SME for CRA-related processes • Willingness to attend investigator meetings virtually or face-to-face • Willingness to perform feasibility, site selection, site activation, SIV, co-monitoring, and working-group activities as required

🏖️ Benefits

• Annual bonus: 15% • Medicover • Multisport • Life insurance • Private pension plan • Flexible workplace culture supporting work-life harmony • Reasonable adjustments for disability inclusion