Clinical Research Coordinator

Clinical Research Coordinator Job Description:

PURPOSE

To work as an integral member of Investigator site staff maintaining the day-to-day relationship with sites and assist in the development of the network. This includes planning, coordinating and, as appropriate, execution of clinical studies in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor, CRO, and SOP's and any relevant local guidelines and regulations.

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.

MINIMUM REQUIRED EDUCATION, EXPERIENCE AND CERTIFICATIONS

• Appropriate educational qualification and 2 years experience as a CRC (preferred)
• Maintain License/Certification status with appropriate CEU's.
• Cardiopulmonary resuscitation ( CPR) Certification (can be provided upon hire)
• International Air Transport Association (IATA) Certification (can be provided upon hire)
• Good Clinical Practice (GCP) (can be provided upon hire)