Senior Clinical Research Associate II – Site Monitoring

Syneos Health, Inc.; Spain; On-site; EUR 42,000 - 52,000; Full time

Job summary

Syneos Health, Inc. in Galicia, Spain seeks a CRA II dedicated to sponsor monitoring. You will perform site qualification, initiation, interim monitoring, and close-out visits, ensuring regulatory, ICH-GCP, and protocol compliance.

You will verify informed consent, protect patient confidentiality, and support site staff while collaborating with Sponsor teams to maintain data quality and audit readiness throughout the study lifecycle.

Qualifications

• Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
• 3-4 years of experience as CRA.
• Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
• Must demonstrate good computer skills and be able to embrace new technologies
• Experience in Immunology, Cardiology, Pulmonar Hipertension, Ophthalmology or Lipids
• Excellent communication, presentation and interpersonal skills

Responsibilities

• Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
• Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate.
• Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records.
• May perform investigational product (IP) inventory, reconciliation and reviews storage and security.
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Documents 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.
• For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
• May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
• Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
• Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
• Additional responsibilities include: Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff.

Skills

Bachelor’s degree or RN

CRA experience 3-4 years

GCP knowledge

Computer skills

Immunology

Cardiology

Pulmonary Hypertension

Ophthalmology

Lipids

Communication skills

Education

Bachelor’s degree or RN

Job description

Syneos Health, Inc. in Galicia, Spain seeks a CRA II dedicated to sponsor monitoring. You will perform site qualification, initiation, interim monitoring, and close-out visits, ensuring regulatory, ICH-GCP, and protocol compliance.

You will verify informed consent, protect patient confidentiality, and support site staff while collaborating with Sponsor teams to maintain data quality and audit readiness throughout the study lifecycle.