Senior Clinical Research Associate

• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage clinical monitoring documentation, procedures, and sponsor requirements
• Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs
• Build collaborative relationships with investigative sites and client personnel
• Support project managers and clinical team managers, taking a lead role when required
• Mentor, train, and contribute to the development of junior clinical team members
• Monitor investigator sites using risk-based monitoring, root cause analysis, and corrective/preventive actions
• Ensure data accuracy through source document review, source data verification, 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 updates to the Clinical Team Manager
• Update and quality-check clinical trial management systems
• Participate in investigator meetings and identify qualified investigators and sites
• Initiate clinical trial sites and ensure protocol and regulatory compliance
• Conduct trial closeout and retrieve trial materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls
• Facilitate communication among sites, clients, and the PPD project team
• Respond to company, client, and regulatory audits and inspections
• Complete expense reports, timesheets, and other administrative tasks
• Contribute to process improvement initiatives and other project work

• 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 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
• Flexibility and adaptability
• 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 an office, laboratory, clinical, and/or home office environment
• Ability to use personal protective equipment when required
• Ability to work upright and/or stationary for 6-8 hours per day
• Ability to lift and carry objects, luggage, and laptop computer up to 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 accommodation during the application process for job seekers with disabilities