Study Coordinator - K-650

The Nephrology and Kidney Transplantation Research Group is part of the University Hospital Vall d'Hebron (VHUH) located in Barcelona, a tertiary referral public center for Catalunya and many other areas of Spain. The HUVH integrates WomenChildren, General, and Trauma-Orthopedics Teaching Hospitals, providing multidisciplinary care involving all pediatric and adult medical and surgical sub-specialties. We also work closely with the Pediatric Urology Service, accredited as a national reference service for complex urologic surgeries in children and adolescents. Furthermore, we are part of the Renal Physiopathology Group at the Vall d'Hebron Research Institute (VHIR). Our research focuses on Inherited Tubulopathies (Dent disease, Familial hypomagnesemia with hypercalciuria nephrocalcinosis) and rare kidney diseases. In the clinical research field, we are committed to developing new therapies in pediatric patients and participate in several international clinical trials and academic research projects focused on chronic kidney disease in children and rare kidney diseases.

Education and Qualifications:

1. Required:

• Bachelor's Degree in Pharmacy and Master in Clinical Trials
• Additional training in Pediatric Clinical Trials and assessment of biomedical research projects by Clinical Research Ethics Committee (CEIm)
• Fluency in Catalan, Spanish, and English (business level)

• Studying for a PhD
• Training in Good Clinical Practice (GCP) - ICH E2 (R6)

Experience and Knowledge:

1. Required:

• At least 4 years of experience working in clinical trials
• At least 4 years of experience in pediatric hospital environments
• Computer literacy (Office package, mail, eCRF)

• Highly organized and methodical, with strong motivation and initiative
• Excellent communication skills
• Ability to respond quickly to requests from the team and sponsor

Main Responsibilities and Duties:

1. Provide information to potential participants in clinical trials.
2. Conduct and supervise tasks related to clinical trials and research projects.
3. Coordinate with different vendors: sample and medication couriers, digital patient platforms (questionnaires, diaries...), IVRS, payment platforms, home nurses, medical imaging platforms, sample and imaging central laboratories, trial management platforms.
4. Report to Pharmacovigilance: notify and explain the SAEs and follow up on them.
5. Submit applications to the Clinical Research Ethics Committee (CEIm) for research projects.
6. Select, include, and follow up with patients in clinical trials.
7. Handle biological samples: centrifugation, freezing, shipping to central laboratories, etc.
8. Maintain up-to-date clinical data from source documents in eCRFs, CTMS, and ISF.
9. Coordinate clinical trials to ensure compliance with the protocol.
10. Attend site-monitoring visits, review, and resolve queries in accordance with GCP.