Clinical Research Coordinator

Job Summary:

The Clinical Research Coordinator (CRC) manages clinical trials and other research projects. The CRC reviews study protocols, manuals of operation, and other relevant SOPs to guide study visits with subjects and ensure all procedures are performed accordingly; handles administrative activities generally associated with the conduct of research; continuously maintains up to date informed consent with subjects; enters information into the electronic data capture (EDC) system; communicates with the sponsor, monitors, auditors, clinical research organization (CRO), and other governing bodies; documents and communicates adverse events & serious adverse events; resolves study queries; and participates in trainings, particularly in good clinical practice. With appropriate credentialing/training may perform phlebotomy and specimen collection. May perform supervisory duties and train less experienced personnel.

This position supports clinical research activities in clinical and hospital settings. The qualified candidate will be required to undergo hospital credentialing.

Duties/Responsibilities:

• Communicates clearly with study investigators, sponsors, director, IRB, and others regarding study protocols, recruitment, adverse events, etc.
• Assists in developing recruitment strategies and performs screening with potential participants.
• Performs in-person, virtual, and/or telephone-based research visits.
• Reviews patient records, attends recruitment events, directly interacts and cares for research participants
• Develops flow sheets, source documents, and other study related documents.
• Maintains up to date and accurate study documents. Reviews case report forms and audits for accuracy with source documents.
• Implements IRB approved protocol changes to visits and source documentation.
• Participates in sponsor provided webinars, teleconferences, and investigator meetings.
• Prepares/reviews documents for regulatory submission.
• Ensures study information is kept secure and confidential.
• Supervises collection of study specimens and processes specimens.
• Monitors scheduling of procedures, screening, specimen shipping/handling, laboratory kits, and coordinates other services as needed.
• Ensures adequate temperature regulation and documentation for investigational products, laboratory supplies, and other temperature-specific materials.
• Educates participants on investigational products and administers investigational products.
• Ensures compliance and ethical standards are maintained throughout the conduct of the study.
• Provides any other duties and responsibilities as determined by management and physician leadership.
• Abides by all HIPAA and confidentiality regulations and policies.

Supervisory Responsibilities:

• May perform supervisory duties and train less experienced personnel.

Required Skills/Abilities:

• Must be attentive to detail
• Demonstrate a strong history of working in a team environment
• Ability to multi-task
• Have strong communication skills and customer service

Education and Experience:

• High School Diploma or GED and three years of health care, customer service, or administrative support experience OR
• Two years of college in a scientific, health-related, or business program and one year of health care, customer service, or administrative support experience
• Licensed as an LPN/LVN and one year of health care, customer service, or administrative support experience
• Bachelors degree, Masters degree, MD, PhD in a scientific, health-related, or business program

Physical Requirements:

• Ability to lift up to 30 pounds with frequent lifting and/or carrying of objects that weighing 10 pounds
• Ability to walk and/or stand for significant amounts of time