Clinical Research Intern
Roche
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We are seeking a highly organized and detail-oriented Clinical Research Intern to join our team in Hungary. In this role, you will provide essential administrative support to our Country Clinical Operations department. By collaborating with our Study Start-Up (SSU) and Clinical Research Engagement Lead (CREL) teams, you will help advance the preparation, submission, and execution of Roche clinical trials (Phase I-III) across the country. Through this internship, you will gain hands-on experience in study start-up, essential document management, and post-trial access program coordination. You will also develop a strong understanding of Good Clinical Practice (GCP) principles and local clinical trial regulations.
Key Responsibilities
Document & Systems Management
eTMF Management: Assist with site-level and country-level electronic Trial Master File (eTMF) management, ensuring files are accurately updated, complete, and maintained.
Documentation Support: Assist the team with the preparation, handling, distribution, filing, and archiving of clinical study documentation and reports in accordance with the scope of work and Standard Operating Procedures (SOPs).
Compliance Tracking: Support the team in maintaining clinical systems (e.g.: Veeva Clinical) to track site compliance and performance within project timelines.
Quality Control: Assist with the periodic review of study files for completeness and accuracy.
ISF Preparation: Assist in the preparation and distribution of Investigator Site Files (ISF).
Post-Trial Access Programs, Equipment & Supplies
Clinical Trial Supplies: Assist the SSU team with the preparation, handling, distribution, and tracking of Clinical Trial Supplies.
Equipment Calibration: Manage and track equipment calibration to ensure site readiness and compliance.
Post-Trial Access Programs: Coordinate logistics and documentation for post-trial access programs.
Ideal Candidate Profile
Education: Currently enrolled in a higher education program at a Hungarian university. Studies or a background in Life Sciences is a strong plus.
Languages: Fluent in Hungarian and minimum intermediate-level English.
Soft Skills: Ability to work collaboratively in a team environment and manage multiple tasks simultaneously. Strong organizational skills with a keen eye for detail.
Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) or equivalent systems. Experience with or willingness to learn clinical systems.
Internship Details
Working Hours: Minimum requirement of 25-30 hours per week.
Duration: Minimum commitment of 6 months.
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Roche is an Equal Opportunity Employer.
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