Full-Time
Clinical Research Associate
OPIS s.r.l.
Compensation Overview
€48k/yr
Barcelona, Spain + 1 more
More locations: Madrid, Spain
In Person
Bachelor's
Category
 Biology & Biotech (1) |
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Required Skills
Microsoft Office
Requirements
- A degree in a scientific field is required.
- At least 2 years of Clinical Research Associate or clinical trial monitoring experience is required.
- Strong knowledge of ICH-GCP, ISO 14155, and clinical trial processes is required.
- Good English and Microsoft Office skills are required.
- The role requires organizational, communication, and problem-solving abilities.
- The ability to work independently and in a team is required.
Responsibilities
- Identify, assess, and initiate investigational sites.
- Conduct feasibility, pre-study, initiation, monitoring, and close-out visits.
- Ensure compliance with protocols, standard operating procedures, 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, including the trial master file/electronic trial master file and investigator files.
- Write monitoring reports and follow-up communications.
- Collaborate with project teams, sponsors, and site staff.
- Support audits and inspections and mentor junior Clinical Research Associates.
Desired Qualifications
- Experience in oncology and Phase 1 studies is highly desirable.