Clinical Research Coordinator

Apsida has partnered with a global medical research company with an exciting opportunity.

We are currently seeking a clinical research coordinator in Jena, Germany.

Role Objective:

To support the execution of clinical study visits in accordance with the study protocol at a designated site in Germany, ensuring compliance with regulatory and Good Clinical Practice (GCP) standards.

Key Responsibilities:

• Assist the clinical research team in the day-to-day conduct of studies under the supervision of the Principal Investigator (PI), including but not limited to:
• Processing blood, urine, and other biological samples.
• Accurately entering data into electronic Case Report Forms (eCRFs).
• Collaborating with the Clinical Research Associate (CRA) to resolve data queries.
• Maintain and organize study documentation, including CRFs/eCRFs and Data Clarification Forms (DCFs).
• Support the coordination of trial material orders, shipments, and inventory tracking.
• Assist in scheduling study visits and procedures in alignment with subject availability.
• Facilitate preparation for site visits and monitor study supply levels.
• Process and ship laboratory samples in compliance with IATA regulations (dry ice handling experience preferred).
• Ensure all study documentation adheres to ALCOAC principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete).
• Maintain investigator site files and study databases.
• Provide limited patient contact support, such as recording vital signs, as needed.
• Adhere to ICH-GCP, EU Clinical Trials Directive (2001/20/EC), and local regulatory requirements.
• Collaborate with the MRN Project Manager/Clinical Research Lead to ensure protocol adherence and subject safety.
• Submit timely activity reports, timesheets, and expense documentation.

Skills & Qualifications:

Mandatory:

• Prior experience as a clinical research coordinator or similar role, with demonstrated expertise in:
• Source documentation review and eCRF data entry.
• Laboratory sample processing, handling, and shipping.
• ICH-GCP certification (within the last year).
• Bilingual proficiency in English and German.
• Strong organizational skills and ability to manage multiple tasks efficiently.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Flexibility to adapt to varying weekly hours (average 20 hours/week, subject to visit schedules).

To start ASAP and is expected to continue until end of August 2026.