Quality Assurance and Research Education Coordinator
<p style="margin-right: 30.95pt; text-align: justify;"><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt; letter-spacing: -0.05pt;">Nemours is seeking a <strong>Quality Assurance and Research Education Coordinator</strong>. The</span><span style="font-size: 11pt; letter-spacing: -0.2pt;"> </span><span style="font-size: 11pt; letter-spacing: -0.05pt;">purpose</span><span style="font-size: 11pt; letter-spacing: -0.25pt;"> </span><span style="font-size: 11pt;">of</span><span style="font-size: 11pt; letter-spacing: -0.25pt;"> </span><span style="font-size: 11pt; letter-spacing: -0.05pt;">the</span><span style="font-size: 11pt; letter-spacing: -0.2pt;"> <strong>Q</strong></span><span style="font-size: 11pt; letter-spacing: -0.05pt;"><strong>uality Assurance Research Coordinator</strong> position is to ensure compliance with</span><span style="font-size: 11pt; letter-spacing: -0.2pt;"> </span><span style="font-size: 11pt;">respective research protocols, applicable federal and state regulations, ICH-GCP guidelines and all relevant institutional policies and procedures. The Research Quality Assurance and Education coordinator will provide internal </span><span style="font-size: 11pt; letter-spacing: -0.05pt;">monitoring</span><span style="font-size: 11pt; letter-spacing: -0.3pt;"> </span><span style="font-size: 11pt; letter-spacing: -0.05pt;">and</span><span style="font-size: 11pt; letter-spacing: -0.35pt;"> </span><span style="font-size: 11pt; letter-spacing: -0.05pt;">educational</span><span style="font-size: 11pt; letter-spacing: -0.3pt;"> </span><span style="font-size: 11pt; letter-spacing: -0.05pt;">opportunities for Nemours Biomedical Research to support these objectives. </span></span></p><h3 style="text-align: justify;"><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt; letter-spacing: -0.05pt;">Qualifications:</span></span></h3><ul><li><p><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Certified Clinical Coordinator either through SOCRA or ACRP required</span></span></p></li><li><p><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Bachelor's degree required</span></span></p></li><li><p><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">A minimum of 3 years of relevant experience required </span></span></p></li><li><p><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Experience dealing with regulatory agencies required</span></span></p></li></ul><p>Primary Responsibilities:</p><ul style="list-style-type: disc; padding-left: 24px;"><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Ensure the Sponsor, Investigator, and study team adhere to current FDA regulations, applicable ICH/GCP guidelines, local policies and standard operating procedures. </span></span></li><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Assist in the development and writing of clinical trial monitoring plans based on risk based monitoring.</span></span></li><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Adhere to monitoring plans; e.g. monitoring visit type, frequency, and required critical monitoring activities by utilizing monitoring tracking forms and other monitoring related tools and templates. </span></span></li><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Monitor clinical trial progress through a combination of data review and on site/remote monitoring visits. </span></span></li><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Verify that trial data is consistent with patient clinical notes and other source documentation (source data verification/review). </span></span></li><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Independently coordinate ongoing and upcoming monitoring assignments </span></span></li><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Meet expected timelines for completion of monitoring activities and submission of written monitoring reports. </span></span></li><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Provide recommendations and guidance to study specific monitoring teams and assist in </span></span></li><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">audit readiness and preparation. </span></span></li><li><span style="font-family: Calibri, sans-serif;"><span style="font-size: 11pt;">Provides training programs for clinical research associates developed by the Quality Assurance and Research Program.</span></span></li><li><span style="background-color: white; color: black; font-family: Calibri, sans-serif;"><span style="font-size: 12pt;">Participates in education of new team members as well as ongoing education of teams based on gaps identified through internal audits, sponsor monitoring visits, changes in regulations, departmental/corporate policies and other factors as determined by department leadership</span></span></li><li><span style="color: rgb(64, 64, 64); font-family: Calibri, sans-serif;"><span lang="EN" style="font-size: 11pt;">Must be willing to travel up to 30% of the time as needed</span></span></li><li><span style="color: rgb(64, 64, 64); font-family: Calibri, sans-serif;"><span lang="EN" style="font-size: 11pt;">Must be able to maintain strict confidentiality.</span></span></li></ul><p> </p> <br><p style="margin:0in 0in 0in 42pt">Nemours Children's Health is an internationally recognized pediatric health system serving more than 1.7 million patient encounters each year. We deliver care across six states through two freestanding children’s hospitals — Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida — along with a network of more than 80 primary, urgent, and specialty care practices and more than 40 hospital partnerships.</p> <p style="margin:0in 0in 0in 42pt"><br></p> <p style="margin:0in 0in 0in 42pt">Backed by the Nemours Foundation and Alfred I. duPont Trust, our $1.7B nonprofit system is dedicated to improving children's health through clinical care, research, education, advocacy, and prevention. Our Whole Child Health approach focuses equally on prevention and treatment, partnering with communities to help every child thrive.</p> <p style="margin:0in 0in 0in 42pt"><br></p> <p style="margin:0in 0in 0in 42pt">Inclusion and belonging guide our strategy and growth. We are committed to culturally relevant care, reducing health disparities, and fostering an environment where every associate, patient, and family feels supported and valued.</p> <p style="margin:0in 0in 0in 42pt"><br></p> <p style="margin:0in 0in 0in 42pt">Learn more at <a href="https://www.nemours.org" target="_blank">Nemours.org</a>.</p>