You will perform clinical monitoring activities in compliance with ICH GCP and FDA Regulatory requirements.
You will be in charge of overseeing clinical trials and compliance with regulatory requirements for phase I to IV studies, working with diverse hospital teams. You will have to conduct monitoring visits, to obtain details of existing regulations and hospitals requirements. You will ensure full traceability of all essential documents. You will provide ongoing support to Investigators and study site personnel during the study.
Mínimo: The candidates will provide an University degree in life sciences ( Pharmacy, Biology, or similar qualification) with at least two years of experience in monitoring of clinical trials. Knowledge of ICH-GCP guidelines, EU and FDA regulatory requirements and experience in EC submissions, feasibility, pres-study, initiation, close-out and contract negotiations.
We are looking for people with excellent communication skills and computer literacy (MS-Office), with current driving licence and availability to travel. Customer focus and commitment. Fluency in Spanish and English (written and spoken) is a must.
Deseado: The candidates will provide an University degree in life sciences ( Pharmacy, Biology, or similar qualification) with at least two years of experience in monitoring of clinical trials. Knowledge of ICH-GCP guidelines, EU and FDA regulatory requirements and experience in EC submissions, feasibility, pres-study, initiation, close-out and contract negotiations.
We are looking for people with excellent communication skills and computer literacy (MS-Office), with current driving licence and availability to travel. Customer focus and commitment. Fluency in Spanish and English (written and spoken) is a must.