Hybrid CRA II, Multisponsor — Lead Clinical Site Excellence

Syneos Health, Inc.; España; Híbrido; EUR 42.000 - 60.000; Jornada completa

Descripción de la vacante

Syneos Health, Inc. is seeking a CRA II for multisponsor studies in a hybrid setting in Madrid or Barcelona. You will perform site qualification, initiation, monitoring, and close-out visits, either on-site or remotely, ensuring ICH-GCP/GPP compliance and protocol adherence.

You will verify informed consent, protect patient confidentiality, and assess safety and data integrity. Strong coordination with sites, IP handling, and documentation are required to meet study timelines.

Responsabilidades

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies informed consent is properly documented for each subject/patient and protects confidentiality.
• Assesses factors affecting subject safety and data integrity at investigator sites (protocol deviations and pharmacovigilance).
• Conducts Source Document Review of site source documents and medical records; ensures accurate CRF data and timely query resolution.
• Manages IP inventory, reconciliation, and storage, ensuring proper labeling, import/export and release per protocol.
• Maintains ISF and TMF accuracy; archives essential documents per local guidelines and SOPs.

Descripción del empleo

Syneos Health, Inc. is seeking a CRA II for multisponsor studies in a hybrid setting in Madrid or Barcelona. You will perform site qualification, initiation, monitoring, and close-out visits, either on-site or remotely, ensuring ICH-GCP/GPP compliance and protocol adherence.

You will verify informed consent, protect patient confidentiality, and assess safety and data integrity. Strong coordination with sites, IP handling, and documentation are required to meet study timelines.