Clinical Research Coordinator II - Rheumatology

SHIFT: Day (United States of America) Seeking Breakthrough Makers Children’s Hospital of Philadelphia (CHOP) offers countless ways to change lives. Our diverse community of more than 20,000 Breakthrough Makers will inspire you to pursue passions, develop expertise, and drive innovation. At CHOP, your experience is valued; your voice is heard; and your contributions make a difference for patients and families. Join us as we build on our promise to advance pediatric care—and your career. CHOP does not discriminate on the basis of race, color, sex, national origin, religion, or any other legally protected categories in any employment, training, or vendor decisions or programs. CHOP recognizes the critical importance of a workforce rich in varied backgrounds and experiences and engages in ongoing efforts to achieve that through equally varied and non-discriminatory means. A Brief Overview The Division of Rheumatology in close collaboration with the Divisions of Oncology, Immunology, and Gastroenterology have launched a Cellular Therapy Program designed to offer curative approaches to autoimmune and other disorders of immune dysregulation. The focus is on the use of CART-19 therapy for autoimmune diseases such as lupus, dermatomyositis, and scleroderma in children and young adults. This role has a strong emphasis on teamwork and close collaboration with the CAR T cell research team within the Division of Oncology. • Investigation team includes: o Dr. Jon M. Burnham (Rheumatology) o Drs. Caitlin Elgarten and Susan McClory (Oncology) o Dr. Jennifer Heimall (Immunology) o Dr. Judith Kelsen (Gastroenterology) • Under minimal supervision, this role substantially coordinates all clinical research activities within the scope of clinical research protocols. • Duties involve managing the day-to-day activities of the research study under the guidance of PI, coordinating multidisciplinary study visits, data collection, data management, regulatory oversight, adverse event reporting, and sponsor communication. • Skills required include study management, strong communication skills, problem solving, and patient/family communication. This is an extremely exciting time as the field of cellular therapies for autoimmunity is in its infancy - we anticipate lots of growth! What you will do Core responsibilities Adhere to an IRB approved protocol Participate in the informed consent process of study subjects Support the safety of clinical research patients/research participants Coordinate protocol related research procedures, study visits, and follow-up care Screen, recruit and enroll patients/research participants Maintain study source documents Report adverse events Understand good clinical practice (GCP) and regulatory compliance Educate subjects and family on protocol, study intervention, etc. Comply with Institutional policies, standard operating procedures (SOPs) and guidelines Must comply with federal, state, and sponsor policies Related responsibilities Prepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of role Register study on ClinicalTrial.gov as appropriate Complete case report forms (paper & electronic data capture) and address queries Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate Facilitate study close out activities as appropriate Coordinate research/project team meetings Collect, process and ship laboratory specimens Schedule subject visits and procedures Retain records/archive documents after study close out Additional Responsibilities may include Manage study finances including sponsor invoicing & resolving study subject billing issues Develop advertisement materials Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals Organize and/or run study-related meetings locally or across teams (for multi-site projects) Support study team communications and outreach Provide training to junior staff on conduct of research studies Document investigational product (drug/device) accountability Self-monitor and self-audit responsibilities Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals Maintain Clinical Trial.gov Develop Case Report Forms Assignments to include more complex studies Education Qualifications Bachelor's Degree - Required Master's Degree in a related field - Preferred Experience Qualifications At least two (2) years of clinical/research coordination experience - Required At least three (3) years of clinical/research coordination experience - Preferred Skills and Abilities Basic knowledge of IRB and human subject protection Excellent verbal and written communications skills Strong time management skills Ability to collaborate with stakeholders at all levels To carry out its mission, CHOP is committed to supporting the health of our patients, families, workforce, and global community. As a condition of employment, CHOP employees who work in patient care buildings or who have patient facing responsibilities must receive an annual influenza vaccine. Learn more. EEO / VEVRAA Federal Contractor | Tobacco Statement SALARY RANGE: $56,890.00 - $71,110.00 Annually Salary ranges are shown for full-time jobs. If you're working part-time, your pay will be adjusted accordingly. ------------------- At CHOP, we are committed to fair and transparent pay practices. Factors such as skills and experience could result in an offer above the salary range noted in this job posting. Click here for more information regarding CHOP's Compensation and Benefits. Children's Hospital of Philadelphia (CHOP) is the nation's first hospital devoted exclusively to the care of children. Since our start in 1855, CHOP has been the birthplace for countless breakthroughs and dramatic firsts in pediatric medicine. Built on a foundation of delivering safe, high-quality, family-centered care, the Hospital has fostered medical discoveries and innovations that have improved pediatric healthcare and saved countless children’s lives. Today, families facing complex conditions come to CHOP from all over the world, and our compassionate care and innovation has repeatedly earned us a spot on the U.S. News & World Report's Honor Roll of the nation's best children's hospitals.