Responsibilities : Works with a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or Principal Investigator to coordinate/implement study. Evaluates and abstracts clinical research data from source documents. Completes Case Report Forms (CRFs). Enters clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors. Provides supervised contact with research participants or contact for long term follow-up research participants only. Assists with regulatory submissions to the Institutional Review Board (IRB) and works closely with supervising research staff or directly with the Institutional Review Board to submit Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines Assists with clinical trial budgets. Schedules research participants for research visits and research procedures. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. May participate in the development of Investigator Initiated trials for Investigational New Drug applications and/or Device applications Educational Requirements: Bachelor of Science or Bachelor of Arts Degree in biological sciences, preferred, or equivalent experience. Licenses: ACRP/SoCRA (or equivalent) certification preferred. Experience: Two (2) years of directly related experience, or equivalent combination of education and experience
Must demonstrate excellent communication, computer (excel, powerpoint, word), written, verbal, and organization skills. Physical Demands: Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.