DUTIES & RESPONSIBILITIES

• Completing DMCR-required training, including GCP and IATA.
• Maintaining a working knowledge of current FDA regulations, GCP/ICH guidelines, organizational SOPs, guidance documents, and study protocols.
• Maintaining a current, up-to-date curriculum vitae and current licensure to practice.
• Assisting in managing the activities and performance of the clinical staff affiliated with the site.
• Performing clinical-related procedures and/or making important trial-related decisions delegated by the Principal Investigator.
• Performing clinical safety assessments and monitoring for study trial participation to include such items as: physical exams, EKGs, phlebotomy, and lab work evaluation
• Possessing a thorough understanding of the requirements of each protocol.
• Managing the medical care of subjects; protecting the rights and welfare of subjects.
• Ensuring documentation of study-related procedures, processes, and events.
• Attending investigator meetings as necessary for study participation.
• Any other matters as assigned by management

KNOWLEDGE & EXPERIENCE

Education:

• Bachelors or Masters in Nursing

Experience:

• Previous clinical research experience
• Nursing experience in a clinical setting