Reference #: 1007917SHIFT: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's Commitment to Diversity, Equity, and Inclusion

　　CHOP is committed to building an inclusive culture where employees feel a sense of belonging, connection, and community within their workplace. We are a team dedicated to fostering an environment that allows for all to be their authentic selves. We are focused on attracting, cultivating, and retaining diverse talent who can help us deliver on our mission to be a world leader in the advancement of healthcare for children.

　　We strongly encourage all candidates of diverse backgrounds and lived experiences to apply.

　　A Brief OverviewUnder 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 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 (Pl) 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-oncologyclinical research consortia, such as NFCTC and PNOC, and collaborate broadly with institutions through the US and internationally.

　　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 & esolving 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 QualificationsBachelor's Degree RequiredMaster's Degree in a related field Preferred

　　Experience QualificationsAt least two (2) years of clinical/research coordination experience RequiredAt least three (3) years of clinical/research coordination experience Preferred

　　Skills and AbilitiesBasic 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 be fully vaccinated against COVID-19 and receive an annual influenza vaccine.

　　Employees may request exemptions for valid religious and medical reasons. Start dates may be delayed until candidates are immunized or exemption requests are reviewed.

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　　Children's Hospital of Philadelphia is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability or protected veteran status.