Entry Level CRA

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

📋 Description

• Execute studies at designated clinical research sites as an active member of local study teams.

• Serve as the primary liaison with study sites and oversee the conduct of studies.

• Prepare, initiate, supervise, and conclude activities at assigned study sites.

• Contribute to the selection of investigators and activities related to study initiation.

• Prepare and submit necessary regulatory and ethics committee documents when required.

• Educate, assist, and counsel investigators and site personnel on study-related topics and Risk-Based Quality Management (RBQM) principles.

• Verify the completion of mandatory training for site staff and uphold inspection readiness.

• Engage in local study team and national investigator meetings.

• Monitor patient recruitment, site progress, and assess site quality and performance.

• Identify and address study-related challenges and escalate them as necessary.

• Update the Clinical Trial Management System (CTMS) and other relevant platforms with site data.

• Manage study and drug supplies, ensuring proper drug accountability.

• Conduct both remote and on-site monitoring visits, remote data verifications, Source Data Reviews (SDR), Case Report Form (CRF) evaluations, and Source Data Verification (SDV).

• Perform site quality risk assessments and adjust monitoring intensity accordingly.

• Ensure timely resolution of queries and maintain the quality of collected study data.

• Accurately and promptly report Serious Adverse Events and follow-up actions.

• Prepare reports for monitoring visits and provide constructive feedback to Principal Investigators.

• Follow up on pending actions at study sites.

• Escalate issues related to quality, privacy, Clinical Study Protocol (CSP), and compliance with ICH-GCP standards.

• Assist sites in achieving and maintaining inspection-ready Investigator Site Files (ISFs).

• Support audit processes and regulatory inspections.

• Upload essential documents to the electronic Trial Master File (eTMF) and assist in quality control checks.

• Ensure that study documents are prepared for archiving and eTMF completion.

• Provide local market research insights on sites, investigators, and competing studies.

• Ensure compliance with AstraZeneca's ethics, policies, procedures, and relevant legislation.

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

⛳️ Requirements

• 0–2 years of relevant prior experience.

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

• Strong written and verbal communication skills.

• Proficient command of the English language.

• Degree in a scientific field or healthcare, or a combination of education, training, and experience equivalent to a degree.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Competitive salary and performance-based incentives.

• Flexible working arrangements.

• Collaborative and inclusive work environment.