In-house CRA I / In-house CRA II
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Job Description
In-house CRA supporting Precision for Medicine’s oncology and rare disease clinical trials. Managing centralized documentation, eTMF/CTMS data, reconciliations and study metrics remotely from Poland.
Responsibilities:
- 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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