Clinical Research Coordinator II - Clinical Research Coordinator - Neurofibromatosis and Neuro-Oncology

SHIFT:Day (United States of America)Seeking Breakthrough MakersChildren’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 OverviewChildren's Hospital of Philadelphia is hiring in Neuro-Oncology, a sub-section of Oncology. The Neuro-Oncology team is under the direction of Dr. Michael Fisher. We currently have over 80 ongoing clinical research studies, in different phases, that cover an array of tumors that affect the central nervous system (CNS). Our Principal Investigators (Pl) are dedicated to improving the survival outcomes, quality of life, and care of children and young adults with CNS tumors. The PIs are joined with a team of clinical research coordinators, study nurses, nurse practitioners, and other ancillary team members. Our group aims to grow our clinical research further, both within the Children's Hospital of Philadelphia, but also collaboratively with institutions through the US and internationally. We are hiring a Clinical Research Coordinator to support a large multi-institutional observational study. This role functions autonomously in the clinical research setting and is responsible for the management of the regulatory, operational, and patient-facing research tasks for the specific research project(s).What You Will DoCore 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 studiesEducation QualificationsBachelor's Degree RequiredMaster's Degree in a related field PreferredExperience QualificationsAt least two (2) years of clinical/research coordination experience RequiredAt least three (3) years of clinical/research coordination experience PreferredSkills And AbilitiesBasic knowledge of IRB and human subject protectionExcellent verbal and written communications skillsStrong time management skillsAbility to collaborate with stakeholders at all levelsTo 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 AnnuallySalary 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.