Senior Clinical Research Associate

• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage clinical monitoring and site management processes and required documentation
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Apply risk-based monitoring, root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification, and case report form 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 and findings resolution
• Provide trial status tracking and progress updates to the Clinical Team Manager
• Update and quality-check clinical trial management systems and reports
• Participate in investigator meetings and identify qualified investigative sites
• Initiate clinical trial sites and make compliance recommendations
• 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 company personnel, and the PPD 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
• Support mentoring, training, and development of junior clinical team members

• Bachelor's degree in a life science related field or equivalent and relevant formal academic / vocational qualification
• Considerable clinical research monitoring experience comparable to 5+ years
• Demonstrated high level of expertise in all aspects of clinical monitoring
• Expert clinical monitoring skills
• Expert knowledge of FDA guidelines, ICH GCPs, applicable regulations and procedural documents
• Excellent critical thinking, root cause analysis and problem-solving skills
• Proficient in Risk Based Monitoring concepts and processes
• Ability to evaluate medical research data and proficient knowledge of medical terminology
• Excellent oral and written communication skills
• Ability to maintain customer focus
• Excellent interpersonal skills
• Excellent organizational and time management skills
• Strong attention to detail
• Ability to remain flexible and adaptable
• Effective presentation skills
• Good digital literacy and proficient knowledge of Microsoft Office
• Ability to work in office, laboratory, clinical, and/or home office environments
• Ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work with required personal protective equipment and potential exposure to biological fluids/infectious organisms
• Ability to work upright and/or stationary for 6–8 hours per day
• Ability to lift and carry up to 15–20 lbs
• Regular and consistent attendance

• Annual incentive plan bonus
• Healthcare
• Employee benefits
• Career and development prospects
• Innovative, forward-thinking company culture
• Accessibility assistance or accommodation during the job application process