Clinical Research Associate (CRA)

CRA

We are looking for a dynamic and motivated junior CRA/Clinical Study Coordinator to fill a hybrid position, combining responsibilities of a Junior Clinical Research Associate (CRA) (60%) and a Clinical Trial Site Coordinator (40%). The ideal candidate will support clinical trial activities across multiple sites, ensuring compliance with GCP and study protocols, while providing hands-on coordination and data entry support at the site level.

Junior CRA Responsibilities:

1. Conduct feasibility and site qualification visits.
2. Prepare and conduct site initiation visits, monitoring, and site closure in accordance with GCP and study procedures.
3. Write visit reports and contribute to study progress reports for the project team and sponsor.
4. Train the principal investigator and the investigational team on the study protocol, documentation, and study procedures.
5. Ensure investigator adherence to GCP standards.
6. Ensure adequate filing and maintenance of documents in the Investigator Site File.
7. Retrieve the essential documents required for the Trial Master File.
8. Monitor patient enrollment progress and follow up on site performance and inclusions.
9. Oversee materials and products in the sites, including returns of materials.
10. Perform source data verification and ensure the accuracy and quality of collected data.
11. Support regulatory document reviews as part of EU legal representation activities.

Clinical Trial Site Coordinator Responsibilities:

1. Act as the primary contact between the Sponsor or CRO and the site.
2. Track patient enrollment and actively support the site in achieving enrollment goals.
3. Perform accurate and timely data entry into study-specific eCRF and address queries promptly.
4. Maintain study-specific and general tracking of documents at the site level.
5. Manage site-specific documentation and maintain regulatory compliance at the site level.
6. Assist in scheduling and preparing for monitoring visits, audits, and inspections.

Minimum Requirements:

1. Bachelor’s degree in Life Sciences/Health/Pharmacy.
2. Mastery of GCP/ISO14155 (valid certification required) and regulations in force.
3. Operational field experience: At least 1-year experience as CRA or a combination of CRA and other clinical research relevant experience.
4. Excellent organizational and multitasking abilities.
5. Strong interpersonal and communication skills to engage with site staff and sponsors effectively.
6. Proficiency in data entry and familiarity with eCRF systems.
7. Problem-solving mindset and attention to detail.