CRA I

This is a fully remote position, open to applicants in Spain.

📋 Description

• Conduct site qualification, initiation, interim monitoring, site management tasks, and close-out visits either on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and protocol requirements.

• Assess the performance of the site and site staff, offering recommendations for site-specific actions.

• Report serious issues to the project team and formulate action plans.

• Verify the informed consent processes and the associated documentation.

• Safeguard subject/patient confidentiality while evaluating risks related to safety and clinical data integrity.

• Review site processes in accordance with the Clinical Monitoring/Site Management Plan.

• Conduct source document evaluations and review medical records.

• Ensure the accuracy and completeness of clinical data recorded in case report forms.

• Resolve queries both remotely and on-site within established timelines.

• Utilize hardware and software for the review and capture of clinical project data.

• Confirm compliance with electronic data capture protocols.

• Perform inventory management, reconciliation, and storage/security assessments of investigational products as required.

• Review Investigator Site Files and align them with the Trial Master File.

• Document activities through confirmation letters, follow-up correspondence, trip reports, and communication logs.

• Assist in strategies for subject/patient recruitment, retention, and awareness.

• Monitor observations, ongoing status, and action items until resolution.

• Oversee site-level activities and communications to fulfill project objectives, deliverables, and timelines.

• Serve as a liaison with project site personnel, ensuring that assigned sites and team members are adequately trained and compliant.

• Participate in investigator, sponsor, global clinical monitoring, and training meetings.

• Facilitate audit preparedness and follow-up actions related to audits.

• For Real World Late Phase: support sites throughout the study lifecycle, perform chart abstraction and data collection, and collaborate with sponsor affiliates, medical science liaisons, and local country staff.

⛳️ Requirements

• A Bachelor's degree or RN in a related field, or an equivalent combination of education, training, and experience is required.

• A minimum of 1 year of experience in a CRA role is essential.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Must be able to manage travel requirements of up to 75% on a regular basis.

🏝️ Benefits

• Opportunities for career development and progression.

• Supportive and engaged line management.

• Technical and therapeutic area training.

• Peer recognition.

• Comprehensive total rewards program.

• Inclusive organizational culture.

• Reasonable accommodations provided, when appropriate, under the Americans with Disabilities Act.