Senior Clinical Research Associate

• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and sponsor procedures
• Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations and SOPs
• Develop collaborative relationships with investigative sites and client personnel
• Assist project managers or clinical team managers and lead where required
• Mentor, train and contribute to developing junior clinical team members
• Monitor investigator sites using a risk-based monitoring approach
• Apply root cause analysis, critical thinking and problem-solving to identify failures and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification and CRF review
• Assess investigational product inventory and records
• Prepare timely reports and letters and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Participate in investigator payment processes and findings resolution
• Track trial status and provide progress updates to the Clinical Team Manager
• Update and quality-check clinical trial management systems and reports
• Participate in investigator meetings and identify qualified investigators/sites
• Initiate clinical trial sites and ensure regulatory and ICH-GCP compliance
• Conduct trial closeout and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools and additional study tasks
• Facilitate communication between sites, client company and project team
• Respond to company, client and regulatory requirements, audits and inspections
• Complete expense reports and timesheets
• Contribute to process improvement initiatives

• 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
• Ability to utilize problem-solving techniques in a constantly evolving environment
• Good digital literacy and proficient knowledge of Microsoft Office
• Ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work in an upright and/or stationary position for 6–8 hours per day
• Frequent mobility required
• Ability to lift and carry 15–20 lbs
• Ability to access and use a variety of computer software
• Ability to communicate complex information clearly
• Regular and consistent attendance

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