In-house CRA I, In-house CRA II

Job not on LinkedIn

🔥 57 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
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• No salary listed.

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Precision For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Provide non-site-facing operational and administrative support to assigned CRAs and clinical project teams throughout the study lifecycle • Prepare and maintain Investigator Site Files, including document distribution and shipping-vendor coordination where required • Remotely review electronic Investigator Site Files for completeness and identify documents requiring CRA follow-up or Trial Master File filing • Review CRA and CTM documents for legibility, completeness, orientation and filing readiness, and file documents in the eTMF • Review the eTMF for missing or expiring site documents and provide follow-up lists to CRAs • Reconcile Delegation of Authority Logs, CTMS, eTMF and system-access records • Set up and maintain site-level data, milestones and activities in CTMS and other study systems • Run reports and provide site metrics, including data-cleaning, enrollment and approval-status information where applicable • Support sample tracking and vendor or study reconciliations, identify discrepancies and provide findings to CRAs • Complete non-site-facing administrative actions arising from CRA contacts or monitoring visits • Support audit and inspection readiness documentation and tracking • Maintain study tracking and reporting, and escalate risks, delays or data inconsistencies • Perform activities in accordance with ICH-GCP, applicable regulations, company and sponsor SOPs, project plans and study-specific procedures

🎯 Requirements

• Bachelor’s degree or international equivalent, preferably in a scientific, healthcare or related discipline, or an equivalent combination of education and relevant experience • Initial experience in clinical research, clinical trial administration or study coordination within a CRO, pharmaceutical or biotechnology environment • Practical experience using CTMS, eTMF and other clinical trial systems or tools • Familiarity with ICH-GCP principles and clinical trial documentation • Strong written and verbal communication skills in English • Strong organization, prioritization and follow-through across multiple studies, sites and deadlines • High attention to detail and accurate document and data review ability • Ability to identify discrepancies, communicate findings clearly and escalate issues appropriately • Ability to work independently in a remote environment while collaborating with CRAs, CTMs and cross-functional partners • Proficiency in Microsoft Outlook, Word, Excel and PowerPoint • Must be legally authorized to work in Poland without employer sponsorship • Preferred: experience supporting multiple studies or countries in a centralized or regional clinical operations model • Preferred: experience with Veeva Clinical applications

🏖️ Benefits

• High retention culture • Remote work in Poland • Regional support role with no required local language for each supported European country • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities

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