Site Management Associate I Madrid Barcelona
hace 5 días
Syneos Health, Inc. is looking for a highly motivated and organized Clinical Research Associate I (CRA I) to join our team in Spain. As a key member of our clinical operations team, you will be responsible for performing site qualification, initiation, interim monitoring, site management, and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) compliance. You will use your expertise to evaluate overall site performance and provide recommendations regarding site-specific actions, communicating serious issues to the project team. This role involves verifying informed consent processes, protecting subject/patient confidentiality, assessing factors affecting safety and data integrity, and applying query resolution techniques remotely and on-site. You will also verify required clinical data entered in case report forms (CRFs) is accurate and complete via review of site source documents and medical records. This position requires knowledge of electronic data capture requirements, investigational product inventory, reconciliation, reviews storage, and security. You will document activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Additionally, you will understand project scope, budgets, and timelines, manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met. You must be able to quickly adapt to changing priorities to achieve goals/targets. May act as primary liaison with project site personnel, ensuring all assigned sites and project-specific site team members are trained and compliant with applicable requirements. Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings, participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable). Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Salary: $ $78,000 - $105,000 annually based on location and qualifications.
Your Responsibilities
- Perform site qualification, initiation, interim monitoring, site management, and close-out visits ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) compliance.
- Evaluate overall site performance and provide recommendations regarding site-specific actions.
- Communicate serious issues to the project team.
- Verify informed consent processes.
- Protect subject/patient confidentiality.
- Assess factors affecting safety and data integrity.
- Apply query resolution techniques remotely and on-site.
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