Clinical Research Associate II

• Conduct remote and on-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 investigational sites and client company personnel
• Support project and clinical team managers and mentor junior clinical team members
• Monitor investigator sites using risk-based monitoring, including root cause analysis, SDR, SDV and CRF review
• Assess investigational product inventory and records
• Document observations and escalate deficiencies through resolution
• Maintain contact with investigative sites between monitoring visits
• Track trial status and provide progress updates to the Clinical Team Manager
• Update and quality-check clinical trial management systems and reports
• Participate in investigator meetings and identify qualified investigative sites
• Initiate clinical trial sites and support trial closeout and retrieval of materials
• Ensure essential documents are complete and conduct on-site file reviews
• Assist with project publications, tools, newsletters, trip report reviews 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 and other project work

• 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
• Frequent travel, generally 60–80%, potentially including extended overnight stays
• Ability to work in an office, laboratory, clinical and/or home office environment
• Ability to work in an upright and/or stationary position for 6–8 hours per day
• Frequent mobility required
• Ability to lift and carry objects weighing up to 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 organization
• Exciting company culture
• Accessibility assistance or accommodation during the job application process for eligible job seekers