Senior Clinical Research Associate

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

📋 Description

• Supervise all facets of study site management to ensure patient safety and uphold data quality.

• Offer site- and project-level direction to maintain audit readiness and assist with audit follow-up actions.

• Keep study-specific trial management tools, systems, and status reports up to date.

• Oversee site start-up activities, including investigator feasibility and recruitment, EC/IRB submissions, regulatory documentation, informed consent, notifications, translations, and meetings.

• Support study budget negotiations and investigator contracts as needed.

• Confirm informed-consent processes and evaluate issues related to patient safety, data integrity, protocol deviations, and pharmacovigilance.

• Conduct pre-study, qualification, initiation, routine monitoring, close-out, and monitoring oversight visits, both on-site and remotely.

• Generate timely monitoring reports and necessary project documentation.

• Aid in patient recruitment, retention, and awareness strategies.

• Review and reconcile Investigator Site Files with Trial Master Files.

• Communicate study-related issues with site personnel and the Precision project and clinical trial management teams.

• Foster relationships with investigators and study staff.

• Manage the inventory, reconciliation, storage, dispensing, and regulatory compliance of investigational products.

• Conduct remote EDC/CRF and patient profile reviews, resolve queries, and assist with data discrepancies.

• Identify and process Serious Adverse Events.

• Recognize site risks, escalate them, and ensure timely resolution.

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

• Assist with protocols, study documentation, CRF design, clinical trial documents, and clinical study reports.

• Mentor and train new hires and junior monitors.

• Engage with clients and take part in proposal activities and presentations.

• Initiate requests for investigator payments.

• Travel as necessary based on project requirements.

⛳️ Requirements

• Bachelor's degree or equivalent experience in a scientific or healthcare field.

• At least 5 years of experience as a CRA in a CRO or the pharmaceutical/biotech industry, or equivalent relevant experience and/or demonstrated competencies.

• Extensive site management experience or equivalent clinical research experience.

• Professional-level proficiency in English, both spoken and written.

• Preferred: advanced degree (graduate or postgraduate).

• Preferred: experience in monitoring rare and complex therapeutic areas.

• Preferred: familiarity with EDC trials and EHR records.

• Preferred: experience in biopharma or a relevant therapeutic area.

• Preferred: country-specific site start-up experience, including feasibility assessments, contract negotiations, and submissions.

• Preferred: capability to monitor sites in accordance with protocol monitoring guidelines, SOPs, GCP, and ICH standards.

• Preferred: ability to address project-related issues and prioritize workload effectively.

• Preferred: willingness to travel overnight; up to 60% travel on average, including international travel as required.

• Preferred for select opportunities: oncology experience, ideally in early phases.

• Preferred: understanding of clinical trial methodology, protocols, and indications.

• Preferred: ability to conduct formal presentations.

• Preferred: skills in continuous improvement and process efficiency.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health, dental, and vision insurance plans.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• Generous paid time off and holiday policies.