In-house CRA I / In-house CRA II

🔥 9 minutes ago

🇵🇱 Poland – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 22%

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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 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 coordination with shipping vendors where required • Route site communication and follow-up to the assigned CRA • Review electronic Investigator Site Files remotely for completeness and identify documents requiring CRA follow-up or filing in the Trial Master File • Review documents for legibility, completeness, correct 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 the assigned CRA • Reconcile Delegation of Authority Log, CTMS, eTMF and system-access records • Set up and maintain site-level data, milestones and activities in CTMS and other study-specific systems • Run reports and provide CRAs with 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 the CRA • Complete non-site-facing administrative actions arising from CRA site contacts or monitoring visits • Provide documentation and tracking support for audit and inspection readiness • Support study tracking and reporting, maintain accurate activity status 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 ability to perform accurate document and data review for extended periods • Ability to identify discrepancies, communicate findings clearly and escalate issues appropriately • Ability to work independently in a remote environment while collaborating effectively with CRAs, CTMs and cross-functional partners • Proficiency in Microsoft Outlook, Word, Excel and PowerPoint • Candidates must be legally authorized to work in the country of employment 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

• Regular full-time employment • Remote work arrangement • Equal opportunity employment • Reasonable accommodation during the application process

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