Clinical Research Coordinator II - RI Rheumatology

Job Description

Essential Functions:

• Conducts clinical studies as outlined in the study protocol; discerns critical elements of the protocol to ensure subject safety throughout study; adheres to good clinical practices.
• Recruits, consents and enrolls subjects according to ICH/GCP regulations, and subjects’ rights through institutional IRB, federal and state regulations; Ensures the subject meets inclusion/exclusion criteria; answers questions related to the protocol procedure as applicable; acts as a patient/family advocate.
• Captures, processes and ships human specimens for use in research studies.
• Identifies study implementation and/or study management issues and works with the study team to develop and implement solutions to ensure study progress and success.
• Aids in the study recruitment plan and provides input into the study budget; manages all screening, enrollment and study participation logs; completes recruitment summary at study termination.
• Creates source documents that facilitate systematic data collection and/or aid in protocol execution and management and record keeping; conducts accurate and timely subject data collection.
• Aids in the study database development to maintain study data in de-identified format, according to recognized skill level; completes Case Report Forms (CRF’s) and ensures CRF’s are completed prior to monitor visits.
• Trains other study personnel with regards to study-specific responsibilities and keeps written documentation of this training.
• Alerts the investigator when the subject’s safety is in jeopardy, there is a protocol deviation, or when the subject requests premature study termination.
• Maintains regulatory binder.
• Assists the principal investigator in the preparation of scientific publications and grant proposals.

  Qualifications

  • Associate's degree or equivalent work-related experience, required.
  • Bachelor's degree, preferred.
  • CRA/CRC certification, preferred.
  • Understanding of medical terminology and clinical trials preferred.
  • Working knowledge of PCs and word processing and data management software.
  • Demonstrated analytical skills with accuracy and attention to detail.
  • Excellent verbal and written communication skills.
  • Goal-oriented and self-directive, ability to manage complex projects independently.
  • Strong organizational and interpersonal skills.
  • Eighteen months experience in clinical research or health care field, required.