Research Associate
Hace 1 día
barcelona, provincia de barcelona, España
OPIS s.r.l.
Jornada completa
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The Clinical Research Associate is responsible for managing and monitoring clinical trials to ensure they are conducted in compliance with study protocols, ICH-GCP, and applicable regulations. This includes site selection, initiation, monitoring, and close-out activities, while ensuring data quality and patient safety. The role reports to the Clinical Project Manager. Conduct feasibility, pre-study, initiation, monitoring, and close-out visits
Perform source data verification and ensure data accuracy and completeness
Write monitoring reports and follow-up communications
Collaborate with project teams, sponsors, and site staff
Support audits/inspections and mentor junior CRAs
Minimum 2 years’ CRA or clinical trial monitoring experience (oncology and phase 1 studies highly desirable)
Strong knowledge of ICH-GCP, ISO14155, and clinical trial processes
Good English and Microsoft Office skills
Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the‑art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.
OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top‑quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.)
Perform source data verification and ensure data accuracy and completeness
Write monitoring reports and follow-up communications
Collaborate with project teams, sponsors, and site staff
Support audits/inspections and mentor junior CRAs
Minimum 2 years’ CRA or clinical trial monitoring experience (oncology and phase 1 studies highly desirable)
Strong knowledge of ICH-GCP, ISO14155, and clinical trial processes
Good English and Microsoft Office skills
Founded in 1998 in Italy and now operating at an international level, OPIS is a full-service science driven biotech focused CRO providing premium trial management for multi-country clinical trials, including state-of-the‑art information technology solutions and innovative approaches to the increasing complexity and variety of current projects.
OPIS added value lies in its highly specialized professionals who can assist their clients using their deep know-how and experience to guarantee a top‑quality level of Clinical Trial Management and ability to operate in a wide range of fields (medical writing, scientific and statistical consultancy for trial design, regulatory activities, pharmacovigilance, etc.)