Title: Patient Screening Manager for leading Clinical Research Site

Location: Clinical Pharmacology of Miami

Job Description:

ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late-stage neuroscience drug development. With 21 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally.

Under the direction of the Site Director the Screening Manager is responsible for overseeing the screening department, compiling daily and weekly screening reports, reporting screening and enrollment information to Clinical Study Managers and executive team, training new screening staff, making the screening schedule, and collaborating with the recruitment & clinical departments. Responsible for accurately documenting all information obtained throughout the clinical research process.

Responsibilities:

• Oversee the day-to-day operations of the Screening Department.
• Participate in study planning (screening, admission and out-patient visits) process with all Department Heads.
• Ensures that screening staff is trained on all current and upcoming protocols.
• Communicate with the study teams to ensure the informed consent forms and all screening documents are prepared and available for screening.
• Ensures the accurate completion of screening study documents and prompt delivery of completed documents to the study team.
• Ensures the completion of the enrollment logs for Pre-Screening/Screening/Screen Failures daily for all studies.
• Regularly attends training meetings, staff meetings, initiation meetings, study start-up meetings, and other meetings as assigned.
• Conducts the informed consent process, per Standard Operating Procedures, as needed.
• Screens and conducts study procedures, as designated on the Delegation of Authority Log, as needed.
• Assists with QA and QC activities on studies.
• Performs annual performance review on screening staff
• Maintains continuous education for the screening department.
• Seeks out to improve operational processes to improve the screening department and improve quality.
• Initiate off cycle staff reviews and/or disciplinary action in conjunction with Site Director and HR specialist, if necessary.

Skills and Qualifications:

• Certification in a clinical or allied health field with a minimum of six months experience in a medical facility.
• Customer Service experience required
• Clinical research experience Required
• Good working knowledge of medical terminology and the clinical research process
• Maintains current licensure, registration and/or certification within educational background
• Maintains necessary CEU’s for registration and/or certification