Clinical Research Coordinator

Breakthrough Maker Opportunity at Children's Hospital of PhiladelphiaChildren'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 OverviewDuties involve managing the day-to-day activities of the research study under the guidance of PI or managing study staff. Children'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, who also serves as the Director of the Neurofibromatosis Clinical Trials Consortium (NFCTC). Dr. Cassie Kline is the Director of Clinical Research for Neuro-Oncology, and also serves as the Director of Data Quality and Integration of the Pediatric Neuro-Oncology Consortium (PNOC). We currently have over 50 ongoing clinical trials, in different phases, that cover an array of tumors that affect the central nervous system (CNS). Our Principal Investigators (PI) are dedicated to improve 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 novel clinical trials within the Children's Hospital of Philadelphia, but we are also active members of neuro-oncology clinical research consortia, such as NFCTC and PNOC, and collaborate broadly with institutions through the US and internationally.What You Will DoCore responsibilities:Adhere 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 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 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 include:Manage 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 ClinicalTrial.govDevelop Case Report FormsAssignments to include more complex studiesEducation Qualifications:Bachelor's Degree RequiredMaster's Degree in a related field PreferredExperience Qualifications:At least two (2) years of clinical/research coordination experience RequiredAt least three (3) years of clinical/research coordination experience PreferredSkills and Abilities:Basic 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.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.