Senior Clinical Research Associate

• Conduct remote and on-site investigator site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations and SOPs
• Build collaborative relationships with investigative sites and client personnel
• Apply risk-based monitoring, root cause analysis and corrective/preventive actions
• Ensure data accuracy through SDR, SDV and CRF review
• Assess investigational product inventory and records
• Document observations and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Track trial status and provide progress reports to the Clinical Team Manager
• Update clinical trial systems, including CTMS, and perform report quality checks
• Participate in investigator meetings and identify qualified investigators
• Initiate clinical trial sites and ensure trial closeout and material retrieval
• Ensure essential documents are complete and conduct on-site file reviews
• Support project publications, tools and additional study tasks
• Facilitate communication among sites, clients and the PPD project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Contribute to project initiatives and process improvement

• Bachelor's degree in a life science related field or equivalent and relevant formal academic / vocational qualification
• 5+ years of clinical research monitoring experience or comparable experience
• 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
• Proficient knowledge of medical terminology
• Excellent oral and written communication skills
• Ability to maintain customer focus
• Excellent interpersonal, organizational and time management skills
• Strong attention to detail
• Flexibility and adaptability
• Effective presentation skills
• Good digital literacy and proficient knowledge of Microsoft Office
• Ability to travel frequently, generally 60–80%, with possible extended overnight stays
• Ability to work in an office, laboratory, clinical and/or home office environment
• Ability to work upright and/or stationary for 6–8 hours per day
• Ability to lift and carry 15–20 lbs
• Regular and consistent attendance

• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Career and development prospects
• Innovative, forward-thinking company culture
• Accessibility assistance or accommodations during the job application process for job seekers with disabilities