Clinical Research Coordinator II - Cellular Therapy and Transplant Section

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 CHOP Cellular Therapy and Transplant Section (CTTS) is seeking candidates with relevant experience to join its Clinical Research Team. This is an exciting area of growth in CTTS @ CHOP which is one of the most active pediatric cell therapy programs in the world. This is a full-time position located in Philadelphia, PA, USA. The successful candidate will be joining a team that implements outstanding cutting edge clinical, translational and outcomes research while providing outstanding clinical care to the patients we serve. Areas of research include CAR-T, and other cell and gene therapies. Your work will directly impact how we treat children with various cancers and other devastating diseases! We offer a unique and exciting multi-disciplinary environment in which to work. Applicants for this position must have demonstrated excellent qualifications, be able to work independently, be flexible and want to work in a team. You can learn more about CTTS at: https://www.chop.edu/centers-programs/cellular-therapy-and-transplant-section What you will do Core responsibilitiesAdhere to an IRB approved protocolParticipate in the informed consent process of study subjectsSupport the safety of clinical research patients/research participantsCoordinate protocol related research procedures, study visits, and follow-up careScreen, recruit and enroll patients/research participantsMaintain study source documentsReport adverse eventsUnderstand good clinical practice (GCP) and regulatory complianceEducate subjects and family on protocol, study intervention, etc.Comply with Institutional policies, standard operating procedures (SOPs) and guidelinesMust comply with federal, state, and sponsor policiesRelated responsibilitiesPrepare, manage, submit, and maintain essential regulatory documents (e.g. IRB, FDA, etc.) and remain aware of the regulatory status for projects within scope of roleRegister study on ClinicalTrial.gov as appropriateComplete case report forms (paper & electronic data capture) and address queriesFacilitate pre-study, site qualification, study initiation, and monitoring visit as appropriateFacilitate study close out activities as appropriateCoordinate research/project team meetingsCollect, process and ship laboratory specimensSchedule subject visits and proceduresRetain records/archive documents after study close outAdditional Responsibilities may includeManage study finances including sponsor invoicing & resolving study subject billing issuesDevelop advertisement materialsAct as liaison for research subject, investigator, IRB, sponsor, and healthcare professionalsOrganize and/or run study-related meetings locally or across teams (for multi-site projects)Support study team communications and outreachProvide training to junior staff on conduct of research studiesDocument investigational product (drug/device) accountabilitySelf-monitor and self-audit responsibilitiesDevelop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manualsMaintain Clinical Trial.govDevelop Case Report FormsAssignments to include more complex studies Education Qualifications Bachelor's Degree - RequiredMaster's Degree in a related field - Preferred Experience Qualifications At least two (2) years of clinical/research coordination experience - RequiredAt least three (3) years of clinical/research coordination experience - Preferred Skills and Abilities Basic knowledge of IRB and human subject protectionExcellent verbal and written communications skillsStrong time management skillsAbility 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: $58,300.00 - $72,900.00 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.