Clinical Research Coordinator

1 week ago


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

PRIMARY RESPONSIBILITIES INCLUDE:

· Evaluating prospective patients for eligibility in clinical trials and effectively communicating trial information.

· Facilitating the informed consent process and ensuring patient enrollment in accordance with protocols.

· Overseeing patient care to align with protocol specifications.

· Collaborating with physicians to assess patient conditions, document adverse events, and ensure protocol adherence.

· Ensuring precise and timely data collection, documentation, and reporting, while participating in monitoring and auditing processes.

· Maintaining all necessary regulatory documentation.

· Engaging in mandatory training and educational initiatives, while educating clinic personnel on clinical research practices.

· Potentially supervising the preparation of physician orders to guarantee protocol compliance.

· Communicating study requirements with physicians effectively.

· Upholding a safe environment for patients, families, and clinical staff by adhering to all relevant federal, state, and professional regulations.

· Accurately managing and documenting the receipt and usage of Investigational Products from sponsors.

· Ensuring strict patient confidentiality in accordance with HIPAA regulations and applicable laws.

· Complying with GCP, ICH, HIPAA, NIH, FDA regulations, and SOP guidelines.

· Contributing to the company's growth with potential future supervisory responsibilities.


QUALIFICATIONS:

· Exceptional customer service skills.

· Self-motivated and proactive.

· Outgoing personality with strong recruitment abilities.

· Phlebotomy experience is essential.

· CCRC certification is advantageous.

· Solid background in the medical field.

· Comprehensive understanding of medical research.

· Excellent verbal and written communication capabilities.

· Proficient in computer use, particularly Microsoft Office.

· Familiarity with ICH Guidelines, GCPs, and FDA regulations.

· Ability to manage multiple protocols across various therapeutic areas.

· Detail-oriented with strong organizational skills.

· Willingness to travel as needed.


Educational Background:

· Bachelor’s degree required; Master’s degree preferred.

· Minimum of three years of experience in Clinical Research.

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