Lead, Clinical Research Coordinator

GENERAL STATEMENT OF DUTIES

Coordinates and oversees clinical or field operation of research projects involving human subjects. Leads in assessing, planning, implementing clinical research study protocols/designs. Is responsible for subject consenting, data collection, and regulatory compliance in clinical research studies.

Essential Functions

• Assists with protocol development and/or reviews potential protocols to evaluate their feasibility and implementation within standard clinical practices
• Generates forms and prepares applications for regulatory approvals (e.g. Institutional Review Board), manages regulatory processes and documentation for assigned studies
• Recruits study participants by referrals or by placing advertisements on television, radio, or in newspapers
• Schedules study appointments; screens and evaluates potential participants to ensure they meet eligibility requirements; obtains informed consent to participate in studies.
• Manages, monitors and participates in research activities including data collection, data entry, and analysis for a research project.
• Completes case report forms for study participants and documents applicable data in study records/databases.
• Schedules and/or coordinates the scheduling of required laboratory tests, imaging studies, and/or exams
• Evaluates and/or develops patient educational materials and provides patient and/or family members with instructions on investigational drug/device administration and other pertinent information related to study participation.
• Trains coordinates and educates patient care team in the conduct of study protocols
• Inventories and requisitions research study supplies and equipment; arranges for repair and maintenance of equipment
• Coordinates and participates in monitoring visits with sponsors and regulatory agencies
• Ensures clinical research is conducted in compliance with all applicable SOPs, laws, and standards
  
  
  

EDUCATION

• Bachelor's degree AND three years of clinical trial experience OR Associates Degree AND Certified Clinical Research Coordinator
  
  
  

Experience

• Four plus years experience in the health care field or an equivalent combination of education and experience.
• Certified Clinical Research Coordinator Preferred
  
  
  

KNOWLEDGE

• Knowledge of the principles, practices, and techniques of clinical care
• Knowledge of clinic policies and procedures
• Knowledge of computer systems and applications
• Knowledge of medical practices, terminology
• Knowledge of organizational policies and procedures
• Knowledge of clinical research regulatory guidelines and regulations
  
  
  

Skills

• Skill in planning and organizing clinical trials
• Skill in evaluating the effectiveness of existing methods and procedures
• Skill in communicating with internal and external customers
  
  
  

Abilities

• Ability to communicate clearly and effectively
• Ability to set priorities among multiple projects
• Ability to interact with providers, clinic and hospital staff
  
  
  

ENVIRONMENTAL WORKING CONDITIONS

• Normal office environment.
• Work in clinical and hospital environments.
• Some travel within the community.
• Limited travel outside of the community.
  
  
  

PHYSICAL/MENTAL DEMANDS

• Requires sitting and standing associated with a normal office environment.
• Some bending and stretching are required.
• Manual dexterity using a calculator and computer keyboard.
  
  
  

Organizational Requirements

• HOPCo Mission, Vision, and Values must be read and signed.
  
  
  

This description is intended to provide only basic guidelines for meeting job requirements. Responsibilities, knowledge, skills, abilities, and working conditions may change as needs evolve.