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 position :

· Conduct feasibility and site qualification visits,

· Prepare and conduct site initiation visits, monitoring, site closure in accordance with GCP and study procedures,

· Write visit reports and contribute to study progress reports for project team and sponsor,

· Train the principal investigator and the investigational team on the study protocol, documentation, and study procedures,

· Ensure investigator adherence to GCP standards,

· Ensure adequate filing and maintenance of documents in the Investigator Site File,

· Retrieve the essential documents required for the Trial Master File,

· Monitor patient enrollment progress and follow up on site performance and inclusions.

· Oversee materials and products in the sites, including returns of materials,

· Perform source data verification and ensure the accuracy and quality of collected data.

· Support regulatory document reviews as part of EU legal representation activities.

Clinical trial site coordinator position:

· Act as the primary contact between the Sponsor or CRO and the site.

· Track patient enrollment and actively support the site in achieving enrollment goals

· Perform accurate and timely data entry into study specific eCRF and address queries promptly

· Maintain study specific and general tracking of documents at the site level.

· Manage site-specific documentation and maintain regulatory compliance at the site level.

· Assist in scheduling and preparing for monitoring visits, audits, and inspections.

Requirements

· Bachelor’s degree in Life Sciences/Health/Pharmacy

· Mastery of GCP/ISO14155 (valid certification required) and regulations in force

· Operational field experience: At least 1-year experience as CRA or combination of CRA and other clinical research relevant experience

· Excellent organizational and multitasking abilities.

· Strong interpersonal and communication skills to engage with site staff and sponsors effectively.

· Proficiency in data entry and familiarity with eCRF systems.

· Problem-solving mindset and attention to detail.