In-house CRA I/ In-house CRA II

Precision AQ; Poland; À distance; PLN 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health insurance

Résumé du poste

Precision for Medicine is recruiting In-house CRA I/II to support CRAs and clinical teams from a remote Poland location. This regional role provides centralized, non-site-facing support across European studies and does not require a local language for each country.

The IHCRA collaborates with CRAs and CTMs, maintains study documentation, and ensures data integrity through CTMS/eTMF workflows while adhering to ICH-GCP standards. Prior CRO experience is beneficial.

Qualifications

• Bachelor's degree in science or related field.
• Initial experience in clinical research administration or study coordination.
• Familiarity with ICH-GCP principles and clinical trial documentation.
• Strong written and verbal communication skills in English.

Responsabilités

• Provide non-site-facing operational and administrative support to CRAs and clinical project teams.
• Prepare and maintain Investigator Site Files and coordinate with shipping vendors.
• Review electronic site files remotely for completeness and filing readiness.
• Review documents for legibility and filing readiness and file in the eTMF."
• Run reports and provide site metrics, including data-cleaning and enrollment status."],
• CoT_job_summary_short
• COMPANY NAME: Precision for MedicineKEY POINTS: In-house CRA I/II, remote Poland, regional European support
• job_summary_shortString
• <p>Precision for Medicine is recruiting In-house CRA I/II to support CRAs and clinical teams from a remote Poland location. This regional role provides centralized, non-site-facing support across European studies and does not require a local language for each country.</p><p>The IHCRA collaborates with CRAs and CTMs, maintains study documentation, and ensures data integrity through CTMS/eTMF workflows while adhering to ICH-GCP standards. Prior CRO experience is beneficial.</p>
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• remote
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• international
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• In-house CRA I/II in Poland: market range approx 60k–90k PLN yearly.
• estimated_low
• 60000
• estimated_medium
• 75000
• estimated_high
• 90000
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• PLN
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• yearly
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Connaissances

CTMS experience

Documentation review

English communication

Remote work

Formation

Bachelor's degree in life sciences

Outils

CTMS

eTMF

Veeva

Description du poste

Location: Remote, Poland
Category: Clinical Trial Services
Division: Precision for Medicine
Business Unit: Clinical Solutions
Requisition Number: 7373

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 escalat risk, 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

• 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 elevate 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.

Recruitment Fraud Warning:

Please be aware that fraudulent individuals and websites may impersonate Precision Medicine Group or its affiliates and attempt to obtain personal, financial, or banking information through fake job postings or employment offers. Precision Medicine Group will never request payment, banking details, or other sensitive financial information as part of the recruitment process. If you believe you have been targeted by a recruitment scam, we encourage you to report the incident to your local law enforcement authorities, consumer protection agency, or relevant cybercrime reporting organization in your country. Please also notify us at [e-mail] so we can investigate and take appropriate action.

Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Any data provided as a part of this application will be stored in accordance with our Privacy Policy .

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 [e-mail] .