Senior Clinical Research Associate

• Conduct remote and on-site investigator site visits to assess protocol and regulatory compliance
• Manage clinical monitoring documentation, procedures, and sponsor guidelines
• Ensure trials follow approved protocols, ICH-GCP guidelines, regulations, and SOPs
• Build collaborative relationships with investigative sites and client company 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 risk-based monitoring, root cause analysis, critical thinking, and problem-solving
• 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
• Track trial status and provide progress updates to the Clinical Team Manager
• Update study systems such as CTMS and perform required quality-control checks
• Participate in investigator meetings
• Identify potential investigators and initiate clinical trial sites
• Ensure trial closeout and retrieval of trial materials
• Ensure essential documents are complete and maintained according to ICH-GCP and applicable regulations
• Conduct on-site file reviews
• Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls
• Facilitate communication among investigative 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 work and 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
• 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
• Flexibility and adaptability in a wide range of scenarios
• 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
• Frequent mobility
• Ability to lift and carry 15–20 lbs
• Ability to use a variety of computer software
• Regular and consistent attendance

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits
• Career and development prospects
• Innovative, forward-thinking company culture
• Accessibility assistance or accommodation during the job application process, where required