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    "requisitionDescription": "<div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><div><p><strong id=\"isPasted\"><span style=\"font-size: 16px;\">Location: This role is onsite at CPMI in Miami, FL</span></strong></p><p><span style=\"font-size: 16px;\"><strong id=\"isPasted\">If you are not local to Miami, let&#39;s discuss how to get you there!</strong><br></span></p><p><strong><span style=\"font-size: 18px;\">This is a newly created role at an amazing, top clinical research site located in Miami, FL</span></strong></p><p><br></p><p><strong><span style=\"font-family: arial, sans-serif; font-size: 14px;\">About Company:</span></strong></p><p id=\"isPasted\"><span style=\"font-family: arial, sans-serif; font-size: 14px;\"><strong>Who is ERG?</strong></span></p><p><span style=\"font-family: arial, sans-serif; font-size: 14px;\">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. &nbsp;With 19 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. &nbsp;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.</span></p><p style='font-family: \"Segoe UI\", \"Segoe UI Web (West European)\", -apple-system, BlinkMacSystemFont, Roboto, \"Helvetica Neue\", sans-serif; color: rgb(50, 49, 48); font-size: 18px; font-weight: 400; line-height: 1.3; -webkit-font-smoothing: antialiased; overflow-wrap: break-word; margin: 0px 0px 1.4em; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; letter-spacing: normal; orphans: 2; text-align: left; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial;'><span style=\"font-family: arial, sans-serif; font-size: 14px;\"><strong>About the Role:</strong></span></p><p><span style=\"font-family: arial, sans-serif; font-size: 14px;\">We are seeking a highly qualified Manager/Director of Clinical Operations, <strong>Phase I,</strong> to oversee c</span><span style=\"color: rgba(0, 0, 0, 0.94); font-family: arial, sans-serif; font-size: 14px; font-style: normal; font-variant-ligatures: normal; font-variant-caps: normal; font-weight: 400; letter-spacing: normal; orphans: 2; text-align: start; text-indent: 0px; text-transform: none; widows: 2; word-spacing: 0px; -webkit-text-stroke-width: 0px; white-space: normal; background-color: rgb(255, 255, 255); text-decoration-thickness: initial; text-decoration-style: initial; text-decoration-color: initial; float: none; display: inline !important;\" id=\"isPasted\">linical trials, ensuring protocol adherence, and managing both staff and operational aspects of studies. This role demands strict compliance with GCP, ICH guidelines, and company SOPs. Core duties include staff management, protocol review, quality assurance, and overall study supervision.</span></p><p id=\"isPasted\"><span style=\"font-family: arial, sans-serif; font-size: 14px;\"><strong>Responsibilities:</strong></span></p><ul><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Lead and mentor the clinical operations team to promote a collaborative and efficient environment.</span></span></span></li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Ensure protocol compliance and maintain high-quality standards across studies.</span></span></span></li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Collaborate closely with Principal Investigators and Site Directors to assign studies and develop enrollment strategies.</span></span></span></li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Oversee human resources functions, including staff evaluations, recruitment, and training.</span></span></span></li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Monitor adherence to protocols, reporting any deviations to sponsors and regulatory bodies.</span></span></span></li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Coordinate with Site Director and Principal Investigator to assign primary clinical research coordinators.</span></span></span></li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Review study components with Principal Investigators and Site Directors, identifying areas requiring clarification before study initiation.</span></span></span></li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Conduct study closeout procedures.</span></span></span></li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Perform additional duties as needed to adapt to the evolving needs of CPMI.</span></span></span></li><li style=\"font-family: arial, sans-serif; font-size: 14px;\">Ensure compliance with all applicable regulations and guidelines, including FDA, ICH, and GCP</li></ul><p><span style=\"font-family: arial, sans-serif; font-size: 14px;\"><strong>Minimum Qualifications:</strong></span></p><ul><li style=\"font-family: arial, sans-serif; font-size: 14px;\">Bachelor&#39;s degree in a scientific or healthcare-related field</li><li style=\"font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">7-10 years of experience in clinical operations, including 5+ years in a senior leadership role.</span></span></span></span></span></span></li><li id=\"isPasted\" style=\"font-family: arial, sans-serif; font-size: 14px;\">Strong understanding of FDA, ICH, and GCP regulations and guidelines</li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Strong communication, organizational, and leadership skills.</span></span></span></li><li style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\"><span style=\"box-sizing: border-box; font-family: arial, sans-serif; font-size: 14px;\"><span style=\"box-sizing: border-box;\">Ability to travel as needed and proficiency in Microsoft Word, Excel, and clinical management software.</span></span></span></li><li style=\"font-family: arial, sans-serif; font-size: 14px;\">In-depth knowledge of clinical trial operations, including study start-up, site selection, patient recruitment, monitoring, data management, and study close-out</li><li style=\"font-family: arial, sans-serif; font-size: 14px;\">Experience managing and mentoring a team of clinical operations professionals</li></ul><p><span style=\"font-family: arial, sans-serif; font-size: 14px;\"><strong>Preferred Qualifications:</strong></span></p><ul><li style=\"font-family: arial, sans-serif; font-size: 14px;\">Phase I or early phase experience</li><li style=\"font-family: arial, sans-serif; font-size: 14px;\">Bi-lingual in English and Spanish</li></ul><p id=\"isPasted\"><span style=\"font-family: arial, sans-serif; font-size: 14px;\"><strong>Benefits Overview:</strong></span></p><p><span style=\"font-family: arial, sans-serif; font-size: 14px;\">Our comprehensive benefits package includes:</span></p><ul type=\"disc\"><li style=\"font-family: arial, sans-serif; font-size: 14px;\">Health insurance</li><li style=\"font-family: arial, sans-serif; font-size: 14px;\">Dental &amp; Vision Insurance</li><li style=\"font-family: arial, sans-serif; font-size: 14px;\">Matching 401k Retirement Plan</li><li style=\"font-family: arial, sans-serif; font-size: 14px;\">Paid Time Off (PTO)</li></ul></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>\n",
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