Madrid : Senior Clinical Research Associate

Madrid : Senior Clinical Research Associate

We are seeking a Senior Clinical Research Associate based in Madrid, able to work on-site at least 3 days a week.

Responsibilities

• Work on assigned studies to ensure that human subject protection is maintained, Good Clinical Practice (GCP), and applicable regulations are followed.
• Coordinate and manage clinical site monitoring responsibilities for assigned studies in accordance with contractual agreements, SOPs, and applicable regulatory guidelines.
• May conduct on-site and remote site qualification, site initiation, interim, and site close-out monitoring visits.
• Serve as primary point of contact for site questions relating to study enrolment, conduct, and close-out issues; liaise with appropriate study team members as needed.
• Communicate performance, trends, deficiencies, and concerns to site investigators and project teams.
• Support study start-up activities such as tracking and reviewing study documents, and distributing site activation letters.
• Perform study-related training and manage development and maintenance of study documents, processes and systems.
• Ensure quality and completeness of central and site master files; track and maintain required study documents and perform quality control reviews.
• Track study site and overall study metrics (enrolment, deviations, adverse events, etc.).
• Attend internal and external meetings and provide progress reports and visit documentation as required.
• Potentially support safety activities such as narrative writing and DSMB / CEC coordination.
• Prepare regulatory submissions (OUS) and assist with site audits and audit action items.
• Assess site suitability for investigative studies and participate in site selection input.
• Assist with site budgets and contract negotiations as directed by the project leads.
• Assist in preparing sites for audits and manage audit actions; support sites during audits remotely and onsite as needed.
• Participate in meetings with prospective clients and support training and mentoring of CRAs during visits.
• Manage development / maintenance of monitoring plans, templates, trackers, and site-specific documents.
• Assist in protocol development, investigational plan / brochure, SIV training materials, and study operations development.
• Support Core Laboratory management and data management activities related to CRF development, validation, UAT, and data trend analysis.
• Perform literature searches and register trials on ClinicalTrials.gov as required.

Working conditions

How to apply

Please send your CV in English to

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