Human Sub Research Spec II

This position supports the Cardiology Division as a research coordinator in pharmaceutical and device clinical trials. Typical duties will include but are not limited to: conducting study protocols as the primary coordinator, with responsibility for study start-up activities such as WIRB and RSRB submissions, recruitment and enrollment and entire conduct of given study under the direction of the Principal Investigator. Ensures compliance with all applicable regulatory and institutional requirements and standards as well as compliance with Good Clinical Practice (GCP) guidelines and sponsor requirements. This position is 80% on-site, 20% remote.

Responsibilities

Supports the Cardiology Division as a research coordinator in pharmaceutical and device clinical trials; Conducts study protocols as the primary coordinator; Ensures compliance with regulatory and institutional requirements and Good Clinical Practice (GCP) guidelines; Conducts visits to ensure research participant adherence with protocol requirements; Dispenses investigational medications and devices and performs protocol-required procedures; Recruits, screens, consents, and enrolls patients; Coordinates IRB submissions and regulatory document collection; Receives, distributes, and explains study information; Trains staff on protocol details, informed consent, study activities, source documentation, and case report form completion; Fills out case report forms, creates patient instructions and calendars, schedules patient appointments; Prepares for and participates in sponsor monitoring visits; Collects and reports adverse and serious adverse events to sponsor

Requirements

Bachelor's degree and 2 years of experience in human subject research coordination required; Or equivalent combination of education and experience; Word processing and data analysis software required

Nice to have

Experience as a Phlebotomist preferred; Clinical skills in phlebotomy and EKG’s preferred; SOCRA - Certification In Clinical Research upon hire preferred; Association of Clinical Research Professionals (ACRP) upon hire preferred