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, sponsor procedures, and monitoring guidelines
• Ensure trials comply with approved protocols, ICH-GCP guidelines, regulations, and SOPs
• Develop collaborative relationships with investigational sites and client personnel
• Support project and clinical team managers and lead assigned activities where required
• 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 process failures and corrective/preventive actions
• Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring
• 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
• Track trial status and provide progress reports to the Clinical Team Manager
• Update clinical study systems, including CTMS, and perform CTMS 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 between 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
• Proficiency in Risk Based Monitoring concepts and processes
• Ability to evaluate medical research data
• Proficient knowledge of medical terminology
• Excellent oral and written communication skills
• 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 proficiency in 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 work upright and/or stationary for 6–8 hours per day
• Frequent mobility
• Ability to lift and carry 15–20 lbs
• Ability to access and use a variety of computer software
• Regular and consistent attendance

• Annual incentive plan bonus
• Healthcare
• Employee benefits
• Career and development prospects
• Innovative, forward-thinking organization
• Company culture centered on integrity, intensity, involvement, and innovation