Clinical Research Associate II

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

📋 Description

• Execute and oversee clinical monitoring along with site management tasks.

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

• Manage sponsor protocols, guidelines, and monitoring settings.

• Ensure that trials adhere to sanctioned protocols, ICH-GCP standards, regulations, and SOPs.

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

• Conduct root cause analysis and implement corrective and preventive measures.

• Guarantee data accuracy through the review of source documents, source data verification, and CRF assessments.

• Evaluate the inventory and records of investigational products.

• Prepare monitoring reports and correspondence, escalating deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Participate in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and manage trial closeout along with the retrieval of trial materials.

• Ensure that essential documents are complete and perform on-site file reviews.

• Provide trial status tracking and progress updates to the Clinical Team Manager.

• Update clinical study systems, including Clinical Trial Management Systems.

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

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

• Complete expense reports and timesheets.

• Contribute to project publications, tools, and initiatives for process improvement.

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

⛳️ Requirements

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

• A minimum of 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship.

• Consideration may be given for equivalency through a combination of appropriate education, training, and/or directly related experience.

• Valid driver's license where applicable.

• Demonstrated clinical monitoring expertise.

• Familiarity with medical/therapeutic area knowledge and medical terminology.

• Proficient understanding of ICH GCPs, relevant 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.

• Strong organizational and time management abilities.

• Effective interpersonal skills and meticulous attention to detail.

• Flexibility and adaptability in various situations.

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

• Proficient knowledge of Microsoft Office and the ability to learn relevant software.

• Good command of the English language and grammar.

• Strong presentation skills.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.