03 ago
|
Syneos Health
|
Madrid
03 ago
Syneos Health
Madrid
Experteer Overview In this CRA I–II role, you will oversee clinical site activities to ensure regulatory and protocol compliance across the trial lifecycle. You collaborate with cross-functional teams to monitor data integrity and support site performance for successful study execution. You will work on real-world late-phase studies and sponsor-driven projects, contributing to audit readiness and risk-based monitoring. This is a hands-on, impact-focused position in a mission-driven, collaborative environment.Compensaciones / Ventajas
- Perform site qualification, initiation, interim monitoring, and close-out visits (on-site or remote) with adherence to ICH-GCP and GPP
- Verify informed consent, protect subject confidentiality, and assess factors impacting safety and data integrity
- Conduct source data review, ensure accurate CRF entry, and drive query resolution within timelines
- Manage IP inventory and labeling, and verify IP dispensing per protocol
- Review ISF and TMF alignment, and ensure archival of essential documents
- Support recruitment/retention strategies and data tracking to monitor trial progress
- Prepare for and participate in investigator meetings and sponsor-facing events
- Provide guidance on audit readiness and support follow-up actions
- Maintain up-to-date knowledge of regulatory guidelines and SOPs
- Coordinate site activity within defined project scope, budgets, and timelines
- Train and supervise site staff as needed and liaise with sponsor/local teams
- Assist in Real World Late Phase study design and site identification
- Identify potential sites based on local treatment patterns and HCP networksResponsabilidades
- Bachelor's degree or RN in a related field or equivalent
- Knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements
- Strong computer skills and adaptability to new technologies
- Excellent communication, presentation, and interpersonal skills
- Ability to travel up to 75%
- Compliance with site access information requirements as needed for US sites
- Experience in clinical monitoring or site management is implied
- Proactive and able to adapt to changing prioritiesRequisitos principales
- career development
- supportive line management
- total rewards program
- inclusive culture
- travel opportunities
📌 Cra I-Ii In Madrid. Sponsor Dedicated.
🏢 Syneos Health
📍 Madrid