Principal CRA

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

📋 Description

• Execute and oversee clinical monitoring and site management tasks.

• Carry out both remote and on-site visits to evaluate adherence to protocols and regulations.

• Administer sponsor procedures and guidelines across various monitoring settings.

• Ensure trials are conducted in accordance with approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Safeguard the rights, well-being, and data integrity of subjects.

• Maintain readiness for audits and foster collaborative relationships with investigational sites.

• Monitor investigator sites utilizing a risk-based approach to monitoring.

• Employ root cause analysis, critical thinking, and problem-solving skills to pinpoint site-process shortcomings and recommend corrective/preventive measures.

• Ensure data precision through SDR, SDV, and CRF reviews during both on-site and remote monitoring activities.

• Evaluate investigational products through inventory audits and records assessments.

• Document findings in reports and letters, and escalate any deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Perform monitoring activities in alignment with approved monitoring plans.

• Engage in investigator payment processes.

• Monitor trial status and provide progress reports to the Clinical Team Manager.

• Update study systems like CTMS and conduct necessary quality control checks.

• Participate in investigator meetings and identify potential qualified candidates.

• Initiate clinical trial sites and provide compliance recommendations.

• Ensure trial closeout and the retrieval of trial materials.

• Confirm the completeness of essential documents and conduct on-site file reviews.

• Assist with project publications, tools, newsletters, trip report evaluations, and CRA team discussions.

• Facilitate communication among sites, the client company, and the project team.

• Address company, client, and regulatory requirements, audits, and inspections.

• Complete expense reports and timesheets.

• Contribute to project work and initiatives aimed at process improvement.

• Travel frequently to site locations, generally 60–80%, which may include extended overnight stays.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field or a Registered Nursing certification, or an equivalent relevant academic/vocational qualification.

• A minimum of 2 years of experience as a clinical research monitor.

• Valid driver's license where applicable.

• Equivalent qualifications through a combination of relevant education, training, and/or directly related experience may be considered.

• Proficient clinical monitoring skills.

• Knowledge of medical/therapeutic areas and medical terminology.

• Understanding and application of ICH GCPs, applicable regulations, and procedural documents.

• Strong critical thinking, root cause analysis, and problem-solving abilities.

• Capability to manage Risk-Based Monitoring concepts and processes.

• Excellent oral and written communication skills.

• Ability to communicate effectively with healthcare professionals.

• Customer-focused with strong listening skills and attention to detail.

• Effective interpersonal communication skills.

• Strong organizational and time management capabilities.

• Flexibility and adaptability in various situations.

• Ability to work independently as well as collaboratively within a team.

• Proficiency in Microsoft Office and a willingness to learn necessary software.

• Good command of the English language and grammar.

• Strong presentation skills.

• Ability to comply with sponsor/client/site requirements, including potential vaccination status or other personal information disclosures.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.

• Opportunity to collaborate with a global team.

• Exposure to a variety of clinical trials and pharmaceutical/biotech projects.

• Professional engagement in clinical research innovation and process improvement initiatives.