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 clinical trial documentation and sponsor procedures
• Ensure trials follow approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs
• Build collaborative relationships with investigational sites and client personnel
• Support project managers and clinical team managers, taking a lead role when required
• Mentor, train, and contribute to developing junior clinical team members
• Monitor investigator sites using a risk-based monitoring approach
• Perform root cause analysis and identify corrective/preventive actions
• Ensure data accuracy through SDR, SDV, and CRF review
• Assess investigational product inventory and records
• Prepare timely reports and letters documenting observations
• Escalate deficiencies and track issues through resolution
• Maintain contact with sites between monitoring visits
• Track trial status and provide progress updates to the Clinical Team Manager
• Update clinical trial systems, including CTMS, and perform report quality checks
• Participate in investigator meetings and identify qualified investigators and sites
• Initiate clinical trial sites and ensure regulatory and ICH-GCP compliance
• Ensure trial closeout and retrieval of trial materials
• Review essential documents 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 project teams
• Respond to company, client, and regulatory audits and inspections
• Complete expense reports, timesheets, and other administrative tasks
• 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
• 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, 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 work in an office, laboratory, clinical, and/or home office environment
• Frequent travel to site locations, generally 60–80%, with possible extended overnight stays
• Ability to work upright and/or stationary for 6–8 hours per day
• Frequent mobility
• Ability to lift and carry 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