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.
Key Responsibilities
Identify, assess, and initiate investigational sites
Conduct feasibility, pre-study, initiation, monitoring, and close-out visits
Ensure compliance with protocols, SOPs, ICH-GCP, and regulatory requirements
Perform source data verification and ensure data accuracy and completeness
Monitor patient recruitment and support sites in meeting targets
Ensure proper reporting of adverse events and protocol deviations
Manage investigational product handling, storage, and accountability
Maintain study documentation (TMF/eTMF, Investigator Files)
Write monitoring reports and follow-up communications
Collaborate with project teams, sponsors, and site staff
Support audits/inspections and mentor junior CRAs
Requirements
Degree in a scientific field
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
Strong organizational, communication, and problem-solving abilities
Ability to work independently and in a team
What we offer
Salary up to EUR 55,000/annually based on experience
Additional benefits
Opportunity to develop your career with and expanding company
Please read the information notice on the processing of personal data in the candidates information section of our company website.
Who we are
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 t
📌 Clinical Research Associate (Madrid)
🏢 Opis
📍 Madrid