Clinical Research Associate
hace 3 días
We are seeking an experienced Clinical Research Associate to join our Clinical Operations team in Spain, supporting us in delivering high-quality clinical trials.
Job SummaryThe successful candidate will perform routine site visits, manage assigned sites, and ensure compliance with ICH GCP Guidelines. They will also identify potential risks, prepare CAPA plans, and negotiate study budgets with investigators/institutions.
Responsibilities- Perform routine site visits, including pre-study, initiation, interim monitoring, and closeout visits.
- Manage assigned sites by regular contact with site personnel to ensure site compliance and adequate enrolment.
- Independently perform CRF review, query generation and resolution against established data review guidelines or data management systems.
- Identify and escalate potential risks and identify retraining opportunities for site personnel.
- Prepare corrective and preventive (CAPA) plans for issues identified during monitoring activities and pro-active follow-up of each individual CAPA until timely resolution.
- University degree, preferably in medical or life sciences.
- At least 4 years of individual clinical trial monitoring experience; Oncology and Phase I, or other complex study monitoring is an advantage.
- High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements, and a strong interest in clinical research.
- Fluent in local language and English; both, written and verbal.
- A competitive salary: €60,000 per annum, depending on experience.
- A performance bonus and referral bonus scheme.
- Ongoing training and professional development opportunities.
- A flexible work environment with remote work options.
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