Research Coordinator II

Overview

Job Summary

The research coordinator II is responsible for coordinating the conduct of research protocols with general supervision, assuring that the integrity and quality of the research is maintained and that the research is conducted in accordance with Good Clinical Practice Guidelines, federal, and sponsor regulations and guidelines, BMHCC and BCRI policies and procedures. This includes recruitment, screening, enrollment, randomization and management of the patient per the research protocol. The non-nurse research coordinator II is also responsible for specific protocol implementation and management as well as data collection, patient reported outcomes, and questionnaires as required. The research coordinator II may act as a liaison between the hospital, the IRB, study sponsors, and all investigators. The research coordinator II will collaborate with research coordinators, data managers and regulatory specialists. Other duties may be performed as assigned. Travel may be required.

Job Responsibilities

• Understands and knowledgeable of policies, procedures, and regulations governing human subject's research and incorporates them in securing approval for and the conduct of research.
• Understands the Federal regulations and guidelines governing protection of human subject's, e.g., FDA, OHRP, GCP/ICH, and HIPAA regulations.
• Assists with proficiently preparing and processing new IRB research proposals, amendments, continuing review applications and adverse event reports for IRB submission according to institutional and departmental policies and procedures and federal regulations.
  
• Reports protocol changes including amendments, revisions, updates, closures, safety reports and adverse events to the IRB and study sponsor.
  
• Writes and amends informed consent documents per IRB and study sponsor request.
  
• Submits all updated versions of the protocols and informed consents to the IRB.
  
• Assists in maintaining detailed communication with the IRB regarding all protocols and research subjects.
  
• Implements, coordinates and manages clinical research operations.

Experience

Minimum Required: 4 years Lab, Medical, and/or Research Background

Preferred: 4 years Research Experience

Education

Minimum Required: Associate Degree or equivalent number of years or experience

Preferred: Bachelor's Degree or equivalent number of years or experience

Training

Minimum Required: Knowledge of Medical Terminology

Preferred: Certifications - SOCRA or ACRT Associate of Clinical Research Professional

Special Skills

Minimum Required: Computer skills to include MS Word, Excellant organizational skills. Detail oriented; Experience with EMR and Clinical Trial Management System

Licensure

Minimum Requirement: BLS