Scope of the Job
Responsible for all aspects of research coordination for research studies ; Responsible for research specific quality nursing care for patients participating in clinical trials
• Plan, implement and monitor participant recruitment and retention procedures.
• Screen and interview study participants.
• Maintain case report forms, charts and documentation.
• Review lab and procedure results.
• Dispense medication and maintain records.
• Assures that adverse events are reported in timely fashion.
• Maintain Regulatory documents as mandated by FDA regulations.
• Assist/prepare initial institutional review board (IRB0 and regulatory document submissions. Appropriately submit documents to the IRB.
• Float, Cross Train, and act as back up coordinator for multiple studies.
Must be able to perform under stress when confronted with emergency, critical, or unusual situations. Must be capable of dealing with periodic cyclical workload pressures and levels of responsibility. Required to make independent judgments without supervision. Must be able to make generalizations, evaluations, or decisions based on sound clinical, sensory or judgmental criteria. Must have the adaptability to perform a variety of duties, often changing from one task to another of a different nature without loss of efficiency or composure. Requires the ability to work with people beyond giving and receiving instructions.
• Strong interpersonal skills including a professional and positive demeanor.
• Ability to perform phlebotomy.
• Knowledge of medical terminology.
• Understanding of clinical research process.
• Familiar with the Code of Federal Regulations as they pertain to human subject clinical research and understanding of the clinical research process.
• Possesses critical thinking, prioritization, and organizational skills.
• Computer literate with proficiency in Microsoft Office (Outlook, Word, Excel, Access, and Power Point), Adobe Acrobat, and database management.
• Basic computer literacy and arithmetic skills.
2 yeas Clinical Research required or
certified clinical research required
Educations & Certifications
Certified Clinical Research Coordinator Preferred
Bachelors: Health, Science or Social Science related area preferred.