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 procedures
• Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs
• Develop collaborative relationships with investigative sites and client personnel
• Assist project or clinical team managers and lead activities when required
• Mentor, train, and support 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 resolve site process failures
• Ensure data accuracy through SDR, SDV, and CRF review
• Assess investigational product inventory and records
• Document observations in reports and letters and escalate deficiencies
• Maintain contact with investigative sites between monitoring visits
• Track trial status and provide progress updates to the Clinical Team Manager
• Update clinical study systems and perform CTMS report quality checks
• Participate in investigator meetings and identify potential investigators
• Initiate clinical trial sites and ensure compliance with regulatory and ICH-GCP obligations
• 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, 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 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
• Demonstrated ability to evaluate medical research data
• Proficient knowledge of medical terminology
• Excellent oral and written communication skills
• Ability to maintain customer focus
• Excellent interpersonal, 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 work in an office, laboratory, clinical, and/or home office environment
• Ability to travel frequently, generally 60–80%, including possible extended overnight stays
• Ability to work upright and/or stationary for 6–8 hours per day
• Ability to lift and carry 15–20 lbs
• Regular and consistent attendance

• Annual incentive plan bonus
• Healthcare
• Employee benefits
• Career and development prospects
• Innovative, forward-thinking company culture
• Employee accessibility services and accommodations during the application process