Senior CRA

• Perform and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage sponsor procedures, guidelines, and monitoring environments
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis, critical thinking, and problem-solving to identify site-process failures and corrective/preventive actions
• Ensure data accuracy through source data review, source data verification, and CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Conduct monitoring tasks according to approved monitoring plans
• Participate in investigator payment processes
• Track trial status and provide progress updates to the Clinical Team Manager
• Update clinical study systems, including CTMS, and perform quality-control checks of CTMS reports
• Participate in investigator meetings and identify potential investigators with client companies
• Initiate clinical trial sites and make recommendations regarding site acceptability
• Ensure trial closeout and retrieval of trial materials
• Maintain essential documents and conduct on-site file reviews
• Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls
• Facilitate communication among investigative sites, client companies, and the project team
• Respond to company, client, and regulatory requirements, audits, and inspections
• Complete expense reports and timesheets
• Contribute to project work and process-improvement initiatives

• Bachelor's degree in a life sciences related field, or Registered Nursing certification, or equivalent relevant formal academic/vocational qualification
• 2+ years of experience as a clinical research monitor or comparable experience
• Valid driver's license where applicable
• Equivalency through a combination of appropriate education, training, and/or directly related experience may be considered
• Effective clinical monitoring skills
• Understanding of medical/therapeutic areas and medical terminology
• Understanding and application of ICH GCPs, applicable regulations, and procedural documents
• Critical thinking, root cause analysis, and problem-solving skills
• Ability to manage Risk Based Monitoring concepts and processes
• Effective oral and written communication skills
• Ability to communicate with medical personnel
• Customer focus, listening skills, attention to detail, and ability to identify underlying issues
• Interpersonal, organizational, and time management skills
• Flexibility and adaptability
• Ability to work independently and in a team
• Proficiency in Microsoft Office and ability to learn appropriate software
• Good English language and grammar skills
• Good presentation skills
• Ability to comply with sponsor/client/site requirements, including possible vaccination-status or personal-information disclosure requirements
• Ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work in office, laboratory, clinical, and/or home-office environments
• Ability to use required personal protective equipment

• Fully remote work arrangement
• Standard Monday–Friday work schedule
• Opportunity to work with a global team
• Exposure to projects supporting leading pharmaceutical companies and biotechs
• Professional collaboration and project team participation
• Potential travel and extended overnight stays associated with site monitoring