Senior Clinical Research Associate

• Conduct and coordinate clinical monitoring and site management activities
• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required documentation and sponsor-specific procedures and guidelines
• Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations and SOPs
• Develop collaborative relationships with investigational sites and client personnel
• Support project managers and clinical team managers on assigned projects
• Mentor, train and contribute to the development of 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 SDR, SDV 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 and findings resolution
• Track trial status and provide progress updates to the Clinical Team Manager
• Update and quality-check study systems and CTMS reports
• Participate in investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Ensure trial closeout and retrieval of trial materials
• Maintain essential documents and conduct on-site file reviews
• Assist with 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 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
• 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 office, laboratory, clinical and/or home office environments
• Ability to use personal protective equipment where required
• Ability to work upright and/or stationary for 6–8 hours per day
• Frequent mobility required
• 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 services/accommodations for job seekers with disabilities during the application process