Clinical Research Coordinator

6 days ago


Houston, Texas, United States aQua Dialysis Full time
Job Description

As a Clinical Coordinator at aQua Dialysis, you will play a vital role in the success of our clinical research team. Your primary responsibility will be to coordinate and manage clinical trials, ensuring that all aspects of the trial are conducted in accordance with Good Clinical Practice (GCP) and regulatory requirements.

Key Responsibilities:
  • Screen potential patients for protocol eligibility and present trial concepts and details to patients
  • Participate in the informed consent process and enroll patients on protocol
  • Coordinate patient care in compliance with protocol requirements
  • Review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug, and thoroughly document all findings
  • Responsible for accurate and timely data collection, documentation, entry, and reporting
  • Schedule and participate in monitoring and auditing activities
  • Maintain regulatory documents
  • Participate in required training and education programs
  • Responsible for education of clinic staff regarding clinical research
  • May oversee the preparation of orders by physicians to assure that protocol compliance is maintained
  • Communicate with physician regarding study requirements
  • Provide a safe environment for patients, families, and clinical staff at all times through compliance with all federal, state, and professional regulatory standards
  • Responsible for accurately maintaining and recording Investigational Product receipt from the Sponsor and its use
  • Maintain strict patient confidentiality according to HIPAA regulations and applicable law
  • Adhere to GCP, ICH, HIPAA, NIH, FDA Regulations and SOPs guidelines
  • Contribute to growth of company with future supervisory role
Requirements:
  • Great at customer service
  • Self-motivated/starter
  • Outgoing, excellent recruiting skills
  • Phlebotomy experiences a MUST
  • CCRC certification a PLUS
  • Concrete background in medicine
  • Thorough knowledge of medical research
  • Excellent verbal and written communication skills
  • Proficiency with computers, especially Microsoft office
  • Knowledgeable about ICH Guidelines, GCPs, as well as FDA regulations
  • Able to handle multiple protocols in various therapeutic areas
  • Must be detailed oriented
  • Must be willing to travel to various locations in Greater Houston
Education Experience:
  • Bachelors required, Master degree preferred
  • Minimum of three years in Clinical Research


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