Senior Clinical Research Associate

• Perform feasibility studies for potential sites
• Conduct pre-study, study initiation, interim monitoring, site management, and study close-out visits
• Function as Lead CRA for global studies and coordinate CRAs
• Develop Clinical Monitoring Plans
• Review site visit trip reports and provide feedback and edits
• Mentor and guide less experienced CRAs and site staff
• Design study-specific tools and templates
• Participate in study team, investigator, and bid defense meetings
• Create and conduct training for study team members or colleagues
• Work with Project Management to evaluate deliverables and study milestones
• Compile regulatory and ethical submission documentation
• Coordinate shipment and receipt of study materials
• Document site visit findings in written reports
• Provide input into protocol and CRF design
• Assess, monitor, and train site staff on protocol adherence
• Review subject safety information and informed consent
• Conduct source document verification
• Review paper or electronic CRFs and assist with data query resolution
• Assist sites with Investigator Site File maintenance
• Maintain regular communication with sites
• Update site-related documentation for filing in the Trial Master File
• Ensure site compliance with investigational product receipt, accountability, return, or destruction
• Conduct accompanied site visits for CRA assessment or training
• Complete final site close-out visits and reports
• Ensure quality and timely submission of site data, including safety event reporting and follow-up

• Medical Doctor (MD) degree or Pharmacist degree (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) and a minimum of three years as a Clinical Research Associate
• Four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science and a minimum of five years as a Clinical Research Associate
• Two-year college curriculum or equivalent education/training and a minimum of seven years as a Clinical Research Associate
• Willingness to travel
• Valid current passport
• Driving license
• Fluent in the local languages of the countries under responsibilities
• Proficient in spoken and written English
• Extensive understanding of clinical research principles and processes
• Thorough understanding of FDA and/or EU Directives and regulations, ICH Guidelines, and local regulatory requirements
• Thorough understanding of two to three therapeutic areas
• Thorough understanding of standard operating procedures
• Proficiency in Microsoft Office
• Proficiency with IxRS and EDC systems
• Excellent oral and written communication, planning, organizational, interpersonal, initiative, problem-solving, leadership, and time-management skills

• Diverse and inclusive work environment
• Cohesive and supportive teams
• Accessible, hands-on leaders
• Equal employment opportunities
• Employee experiences focused on appreciation, inclusion, creativity, innovation, and success