RESPONSIBILITIES

• Work directly at patient/subject interface at research sites to deliver high quality patient data in accordance with local regulations, agreed scope of work and as required by protocol.
• Attend and participate in investigator meetings, monitoring visits, audits, seminars and other regional or national meetings.
• Assist with screening and enrollment of subjects into assigned studies.
• Support subjects on trials to encourage maximum retention and future recruitment.
• Assist with the establishment of a recruitment and contingency plan for each study.
• Perform functions necessary for successful completion of all protocol required visits/procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of investigational product, scheduling, drug accountability/reconciliation and organizational tasks, where appropriate and as delegated by the investigator, in accordance with local country requirements.
• Accurately complete source documents and case report forms in both paper and electronic format.
• Assist investigator with recording and reporting of adverse events and SAE’s as per local regulatory authority guidelines.
• Perform other duties as assigned.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

• Sound knowledge of medical terminology.
• Sound knowledge of ICH/GCP and Regulatory requirements.
• Excellent interpersonal and organizational skills.
• Proficient in the use of Microsoft Office and Excel.
• Fluent in local language, spoken and written.
• Fluent in written English language.
• Ability to work independently, prioritize actively, seek input, problem solve and work in a team environment.
• Ability to maintain confidentiality.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.