CRA I, Multisponsor * Hybrid MADRID or BARCELONA *

CRA I, Multisponsor ** Hybrid MADRID or BARCELONA **

Updated: Today
Location: Madrid, Spain
Job ID: 25109351

Description

Syneos Health® is a leading fully‑integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum.

Roles within Clinical Monitoring/CRA are responsible for overseeing and ensuring the integrity of clinical research studies by monitoring data and processes from a centralized location.

Scope of work includes:

• Site qualification, initiation, interim monitoring, site‑management activities and close‑out visits (performed on‑site or remotely); ensuring regulatory, ICH‑GCP or Good Pharmacoepidemiological Practices (GPP) and protocol compliance.
• Verify informed consent processes and protect subject confidentiality.
• Assess factors affecting subject safety and data integrity, including protocol deviations and pharmacovigilance issues.
• For the Clinical Monitoring/Site Management Plan (CMP/SMP), conduct source document review, verify CRF data accuracy, resolve queries, and ensure electronic data capture compliance.
• Perform investigational product inventory, reconciliation and ensure IP dispensation per protocol.
• Review Investigator Site File (ISF) for accuracy and reconcile with Trial Master File (TMF).
• Document activities via letters, reports, and communication logs; track observations and action items.
• Manage site‑level activities, budgets and timelines; adapt to changing priorities.
• Act as liaison with project site personnel and ensure training and compliance.
• Attend investigator meetings, sponsor face‑to‑face meetings and global clinical monitoring staff meetings.
• Support audit readiness and prepare for audits.
• Additional duties for Real World Late Phase studies include site support, chart abstraction, and collaboration with sponsor affiliates.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent education, training and experience.
• Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
• Good computer skills and ability to learn new technologies.
• Excellent communication, presentation and interpersonal skills.
• Ability to travel up to 75% of time.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks. Equivalent experience, skills or education will be considered. The Company complies with the Americans with Disabilities Act and provides reasonable accommodations.