Research Assistant

Gastro Health•Miami, FL

11d

About The Position

Gastro Health is seeking a Full-Time Research Assistant to join our team! Gastro Health is a great place to work and advance in your career. You'll find a collaborative team of coworkers and providers, as well as consistent hours. This role offers: A great work/life balance No weekends or evenings – Monday thru Friday Paid holidays and paid time off Rapidity growing team with opportunities for advancement Competitive compensation Benefits package

Requirements

High School Diploma
Research experience preferred

Responsibilities

Provides assistance to Clinical Research Coordinators, local site, and Central Hub in accordance with federal regulations and sponsoring agency policies and procedures in compliance with Good Clinical Practice.
Performs activities in accordance with established policies and procedures related to clinical research study protocols, including but not limited to: answering phone calls, screening participants for eligibility, and registering subjects in Real Time.
Responsible for organizing the lab, and maintaining inventory of clinical supplies such as lab kits, phlebotomy supplies.
Assist in ensuring that study materials and lab kits are shipped and resupplied as requested.
Supports members of study/project teams; reviews source documents, reviews clinical procedures, drafts new procedures or revisions to existing procedures.
Participate in ongoing clinical and study specific training.
Communicates, as necessary with vendors and supporting functions at site level.
Any other task assigned by the Clinical Research Coordinators and Central Hub
Attends investigator meetings as required or requested by the PI and Clinical Research Coordinator.
Responsible for compiling source documents for active studies and ensuring source binders contain the appropriate documentation to screen upcoming patients.
Prepares other study materials as requested necessary.
Collects data as required by the protocol.
Assures timely completion of Source Documents.
Responsible for processing and shipping labs.
Responsible for assisting in EDC completion.
Completes study documentation and maintains study files in accordance with sponsor requirements and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.
Maintains effective and ongoing communication with the PI, Clinical Research Coordinators, and research participants during the course of the study.
Works with the PI under the Clinical Research Coordinator to manage the day to day activities of the study including problem solving, communication and protocol management.
Assists the Principal Investigator, Clinical Research Coordinator and Regulatory Specialist with archival of study records in accordance with federal regulation, Gastro Health Research policies, and sponsoring agency policies and procedures.