The posting
Precision for Medicine, Oncology and Rare Disease is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high retention rates compared to industry averages. We are now recruiting In-house CRA I/ In-house CRA II to join our team in Poland.
Position summary
The In-house CRA (IHCRA) provides centralized, non-site-facing support to CRAs and clinical project teams across the study lifecycle. The role supports consistent site oversight by maintaining study documentation and systems, reviewing and reconciling site-level data, preparing operational metrics, and completing agreed administrative follow-up activities. The IHCRA works in close collaboration with assigned CRAs and under the oversight of the CTM, escalating issues that require site-facing follow-up or clinical judgment.
This is a regional support role. Direct communication with investigator sites and travel to site visits are not part of the core scope. The role may support studies across European countries and therefore does not require a local language for each supported country.
Essential functions
- 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.
- Where an electronic Investigator Site File is implemented, review it remotely for completeness and identify documents requiring CRA follow-up or filing in the Trial Master File.
- Review documents received from CRAs and CTMs for legibility, completeness, correct orientation and filing readiness, and file documents in the eTMF in accordance with applicable processes.
- Review the eTMF for missing or expiring site documents and provide clear follow-up lists to the assigned CRA.
- Perform scheduled reconciliations between the Delegation of Authority Log, CTMS, eTMF and system-access records; create placeholders or update records as required by the agreed process.
- Set up and maintain assigned site-level data, milestones and activities in CTMS and other study-specific systems based on information provided by the CRA and/or CTM.
- Run available reports and provide assigned CRAs with agreed site metrics, including data-cleaning, enrollment and approval-status information where applicable.
- Support sample tracking and other vendor or study reconciliations, identify discrepancies, and provide findings to the CRA for site-facing follow-up.
- Complete agreed non-site-facing administrative actions arising from CRA site contacts or monitoring visits, such as coordinating supply orders, tracking completion and escalating delays.
- Provide documentation and tracking support for audit and inspection readiness under CRA or CTM direction.
- Support study tracking and reporting, maintain accurate activity status, and escalate risks, delays or data inconsistencies to the appropriate study team member.
- Perform all activities in accordance with ICH-GCP, applicable regulations, company and sponsor SOPs, project plans and study-specific procedures.
Qualifications
Minimum required
- 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.
Skills and competencies
- Strong organization, prioritization and follow-through across multiple studies, sites and deadlines.
- High attention to detail and the 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.
- Self-motivation, flexibility, teamwork and commitment to delivering on agreed responsibilities.
Preferred
- Experience supporting multiple studies or countries in a centralized or regional clinical operations model.
- Experience with Veeva Clinical applications.
Please, apply in English.
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Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at [email protected].
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