Senior Clinical Research Associate

• Perform feasibility studies for potential sites
• Conduct pre-study, study initiation and interim monitoring visits according to protocol requirements
• Function as Lead CRA for global studies and coordinate CRAs
• Develop Clinical Monitoring Plans as requested
• 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 study site staff on protocol adherence
• Review subject safety information and informed consent
• Conduct source document verification for compliance, patient safety and data accuracy
• 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 and return or destruction
• Conduct accompanied site visits for assessment or training of other CRAs
• Complete final site close-out visits and reports
• Perform other duties as assigned

• Medical Doctor (MD) degree or Pharmacist (MSPH, PharmD, PhD, or equivalent Pharmacy degree, etc.) and a minimum of three years as a Clinical Research Associate
• OR a minimum 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
• OR two-year college curriculum or equivalent education/training and a minimum of seven years as a Clinical Research Associate
• Willingness to travel required
• Valid current passport required
• Driving license required
• Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English
• Excellent oral and written communication skills
• Excellent planning and organizational skills with effective time management
• Excellent interpersonal skills
• Initiative and problem-solving skills
• Ability to lead and motivate assigned team, if applicable
• Extensive understanding of clinical research principles and process
• 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

• Equal employment opportunities regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law