Senior CRA

• Conduct remote and on-site visits to assess protocol and regulatory compliance
• Manage required clinical trial documentation and procedures
• Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs
• Develop collaborative relationships with investigational sites and client company personnel
• Apply risk-based monitoring, root cause analysis, critical thinking, and problem-solving to identify site process failures
• Ensure data accuracy through source document review, source data verification, 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 clinical trial systems, including CTMS, and perform report 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 conduct on-site file reviews
• Assist with project publications, tools, trip report reviews, newsletters, and CRA team calls
• Facilitate communication among investigative sites, the client company, 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 improvements

• 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 work in an office, laboratory, clinical, and/or home office environment
• Frequent travel, generally 60–80%, including possible extended overnight stays
• Ability to work in an upright and/or stationary position for 6–8 hours per day
• Ability to lift and carry objects, luggage, and laptop computer weighing up to 15–20 lbs
• Regular and consistent attendance

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