Clinical Research Associate II, Senior, PCRA

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

📋 Description

• Execute and oversee clinical monitoring and site management tasks.

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

• Handle necessary clinical trial documentation and adhere to sponsor-specific procedures.

• Ensure that trials comply with approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs.

• Maintain audit readiness while fostering collaborative relationships with investigational sites.

• Monitor investigator sites through risk-based monitoring, root cause analysis, and corrective/preventive actions.

• Guarantee data accuracy by performing source data reviews, source data verifications, and CRF assessments.

• Evaluate investigational products through inventory checks and records analysis.

• Record observations in reports and correspondence.

• Raise deficiencies and track issues until they are resolved.

• Keep in touch with investigational sites between monitoring visits.

• Conduct monitoring activities in accordance with approved monitoring plans.

• Engage in investigator payment processes and participate in investigator meetings.

• Identify potential investigators and initiate clinical trial sites.

• Carry out trial closeout procedures and retrieve trial materials.

• Ensure all essential documents are complete and properly organized.

• Conduct 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 investigational sites, clients, and the PPD project team.

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

• Complete expense reports and timesheets.

• Assist in project publications and tools, contribute ideas, and support process improvement initiatives.

⛳️ Requirements

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

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

• Valid driver’s license where applicable.

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

• Demonstrated clinical monitoring skills.

• Understanding of medical/therapeutic areas and familiarity with medical terminology.

• Working knowledge 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.

• Customer-focused with strong listening skills, attention to detail, and the ability to identify underlying issues.

• Strong organizational and time-management skills.

• Effective interpersonal abilities.

• Flexibility and adaptability.

• Capacity to work independently as well as in a team setting.

• Proficient in Microsoft Office and ability to learn relevant software.

• Good command of the English language and grammar.

• Strong presentation skills.

• Willingness to travel independently up to 80% by automobile, airplane, and train.

• Ability to work in non-traditional environments and utilize standard office equipment and technology.

🏝️ Benefits

• Support for health and well-being.

• Accessibility services and disability accommodations for the application process.

• Full-time employment opportunities.

• Fully remote work setup.

• Global team and mission-driven work atmosphere.