Senior Clinical Research Associate

🔥 17 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 clinical trial investigator sites • Ensure proper clinical trial conduct according to the Study Monitoring Plan, applicable laws, Good Clinical Practices and Pfizer standards • Manage operational implementation of clinical trial activities from site initiation through database lock • Serve as primary contact for assigned investigator sites during study conduct • Facilitate information flow among study team members, vendors and investigator sites • Perform investigator site development, coaching and training of site personnel • 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 site initiation, routine monitoring and closure • Monitor site-level AEs and SAEs and follow up with investigators to resolve reporting issues • Submit required reports, documentation, updates and tracking within required timeframes • Identify and resolve investigator site issues and develop corrective and preventive actions • Resolve data queries and prepare and conduct site close-out activities • Oversee investigational product receipt, handling, accounting, storage and destruction • Support database release as needed • Undertake unblinded monitor responsibilities where required • Maintain product, protocol and therapy-area knowledge and interact with healthcare professionals • Support the study clinician on patient safety, eligibility and clinical guidance • Drive Quality Event remediation and support audits and CAPA activities when applicable • Mentor and train Clinical Research Associates • Serve as SME for CRA-related processes • Participate in regional or local working groups and 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 capability to perform site management, site monitoring and close-out of assigned clinical trial investigator sites • Knowledge of applicable prevailing laws, Good Clinical Practices and Pfizer standards • Ability to manage investigator site relationships and clinical trial delivery • Ability to resolve protocol-related issues • Ability to conduct onsite and remote/electronic monitoring • Ability to monitor AEs and SAEs and collaborate with the Drug Safety Unit • Ability to manage Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supplies, study progress and metrics • Thorough understanding of the product, protocol and therapy area • Ability to support patient safety, eligibility and clinical guidance to investigators • Ability to drive Quality Event remediation and Audit Observation CAPA development and checks when applicable • Ability to mentor/train Clinical Research Associates • Ability to serve as an SME for CRA-related processes • Ability to perform feasibility, site selection, PTA, site activation checklist coordination, ICD finalization and SIV activities under guidance of a Site Care Partner • Ability to conduct co-monitoring activities as requested

🏖️ 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