Human Sub Research Spec I

Responsibilities

• Captures the administrative details required to initiate and conduct human subject research.
• Coordinates human subject recruitment and screening activities.
• Reviews medical chart history with the Principal Investigator to verify inclusion criteria are met before enrollment.
• Ensures all data are collected and secured within approved parameters and procedures.
• Trains staff on details of protocol, including inclusion and exclusion criteria, informed consent procedures, study activities, source documentation and case report form (CRFs) completion, and adverse event reporting.
• Ensures additional training is provided to ensure changes to protocol and documents are communicated and adhered to.
• Acts as liaison with Sponsor’s Monitor to provide data clarifications, reviews study protocols, ensures thorough understanding and communication, responds to questions that arise during the study, communicates and documents adverse events as advised by the PI and ensures regulatory and other documents, such as consent forms and CRFs, are complete, accurate, and available for review.
• Prepares for, participates in, and serves as liaison for scheduled Sponsor monitoring visits, such as pre-study inspection, initiation, on-going and close out visits.
• Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines and makes recommendations.
• Demonstrates accountability for continuous learning in accordance with Good Clinical Practice standards and guidelines.
• Makes recommendations and implements changes as appropriate.

Requirements

Minimum Education & Experience:

• Bachelor's degree required or Associate's degree and completion of 6 months in the Human Subject Research Coordinator Trainee program required
• Or equivalent combination of education and experience
• Prior experience as a Phlebotomist preferred

Qualifications

Knowledge, Skills And Abilities:

• Word processing and data analysis software preferred