Clinical Research Associate I

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

📋 Description

• Assist in the selection of potential investigators.

• Provide support for study initiation and regulatory upkeep, which includes site qualification visits and necessary regulatory submissions.

• Train, advise, and assist investigators and site personnel on matters related to the study, including Risk-Based Quality Management (RBQM) principles.

• Verify necessary training for site staff and uphold inspection readiness.

• Engage in local study team and national investigator meetings.

• Initiate, oversee, and conclude study sites in accordance with established procedures.

• Communicate patient recruitment and site progress updates to the local study team.

• Enhance site performance, identify and address study-related issues, and escalate them as needed.

• Update the Clinical Trial Management System (CTMS) and other relevant systems with data pertaining to study sites.

• Oversee the management of study and drug supplies, including drug accountability.

• Conduct both remote and on-site monitoring visits along with remote data validations.

• Execute Source Data Reviews, Case Report Form reviews, and Source Data Verifications.

• Carry out site quality risk assessments and adjust monitoring intensity accordingly.

• Ensure prompt resolution of data queries and accurate reporting of Serious Adverse Events.

• Prepare and finalize monitoring visit reports in the CTMS and offer feedback to Principal Investigators.

• Follow up on pending actions from study sites.

• Raise concerns regarding quality, privacy, CSP, and ICH-GCP compliance issues as necessary.

• Assist sites in keeping their Investigator Site Files ready for inspection.

• Provide support during audits and regulatory inspections.

• Gather and upload essential documents into the electronic Trial Master File (eTMF) and prepare documents for final archiving.

• Supply local market research information on sites, investigators, and competing studies.

• Ensure adherence to company policies, ethical standards, and relevant legislation.

• Collaborate with local Medical Science Liaisons (MSLs) as directed.

⛳️ Requirements

• 0–2 years of relevant prior experience.

• Strong understanding of clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Excellent written and verbal communication abilities.

• Proficient command of the English language.

• Degree in a scientific field or healthcare, or an equivalent combination of education, training, and experience may be considered in lieu of a degree.

🏝️ Benefits

• Comprehensive health benefits.

• Opportunities for professional development and training.

• Flexible working hours and remote work options.

• Supportive work environment with a focus on teamwork.