Hybrid CRA II - Multisponsor Trials (Madrid/Barcelona)

Syneos Health, Inc.; Spain; Hybrid; EUR 42,000 - 58,000; Full time

Job summary

Syneos Health is seeking a CRA II (Multisponsor) to join our Hybrid Madrid or Barcelona team. The role focuses on site qualification, initiation, monitoring, and site management to ensure regulatory and GCP compliance across trials.

You will verify informed consent, protect data integrity, perform source data checks, and contribute to TMF/ISF activities while coordinating with study sites and project teams in a multisponsor environment.

Qualifications

• Regulatory and ICH-GCP compliance knowledge.
• Experience with site monitoring and management activities.
• Proficient in IP inventory, labeling, and release processes.
• Experience reconciling ISF with TMF and archiving documents.
• Familiar with pharmacovigilance issues and data integrity.
• Ability to escalate issues to the project team promptly.

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (on-site or remote) ensuring ICH-GCP, GPP and protocol compliance.
• Verifies informed consent and protects subject confidentiality, assessing safety and data integrity.
• Reviews CMP/SMP, conducts Source Document Review, and supports query resolution to timely closure.
• Manages IP inventory, storage, labeling, dispensing and related risks according to the protocol.
• Ensures ISF and TMF reconciliation and archiving per local guidelines.

Skills

Site qualification

Site initiation

Interim monitoring

Site management

ICH-GCP knowledge

Query resolution

Data entry

Tools

EDC

Job description

Syneos Health is seeking a CRA II (Multisponsor) to join our Hybrid Madrid or Barcelona team. The role focuses on site qualification, initiation, monitoring, and site management to ensure regulatory and GCP compliance across trials.

You will verify informed consent, protect data integrity, perform source data checks, and contribute to TMF/ISF activities while coordinating with study sites and project teams in a multisponsor environment.