Senior CRA I

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

📋 Description

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

• Ensure compliance with regulatory standards, ICH-GCP/GPP, and study protocols.

• Assess site and staff performance and recommend specific actions tailored to each site.

• Communicate urgent issues and devise action plans accordingly.

• Verify informed consent procedures, maintain subject confidentiality, and ensure the integrity of safety and clinical data.

• Evaluate site processes and perform source document reviews.

• Validate clinical data in case report forms and address any queries that arise.

• Review the inventory of investigational products, ensuring proper reconciliation, storage, security, dispensing, and administration.

• Examine Investigator Site Files and ensure they are reconciled with Trial Master Files.

• Record monitoring activities through letters, trip reports, communication logs, and project documentation.

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

• Monitor observations, statuses, and action items until resolution.

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

• Collaborate with study site personnel to ensure that site teams are adequately trained and compliant.

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

• Aid in audit readiness, preparation, and follow-up actions.

• Provide ongoing site support throughout the study lifecycle, from site identification to close-out.

• Conduct chart abstraction and data collection.

• Work in conjunction with sponsor affiliates, medical science liaisons, and local country staff.

• Train junior staff upon request.

• Identify and report activities that fall outside of the project scope.

• Recommend potential sites based on local treatment patterns, patient advocacy, and healthcare provider networks.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

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

• Proficiency in computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Capability to manage travel requirements of up to 75% regularly.

• Understanding of local requirements for real-world late-phase study designs.

• Ability to perform chart abstraction and data collection tasks.

• Competence in collaborating with sponsor affiliates, medical science liaisons, and local country staff.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Reasonable accommodations provided when necessary.