Reference #: 1007939SHIFT:Day (United States of America)

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　　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.

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　　A Brief OverviewUnder moderate supervision from study PI or other research study management staff, this role provides substantial coordination level support for all clinical research activities within the scope of clinical research protocols.

　　The Richard D. Wood Jr. Center for Fetal Diagnosis and Treatment (CFDT) is looking for a Clinical Research Coordinator I to work among the Clinical Outcomes Data Archive (CODA) team. The mission of the Clinical Outcomes Data Archive is to analyze longitudinal clinical outcomes data on all patients seen within the CFDT throughout their childhood. Data from CODA is used to answer clinical questions, support quality improvement, and ongoing research studies.

　　Qualified candidates must be able to coordinate clinical research activities under moderate supervision and contribute to methodology for ongoing studies pertaining to multiple Principal Investigators. Experience with data analysis using R Studio, informed consent, and an interest in congenital anomalies is preferred.

　　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 documentsUnder the supervision of PI Report 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 guidelines, and with HIPAA and management of confidential materialsMust comply with federal, state, and sponsor policiesFor multi-site studies or collaborations, support communication and meeting scheduling across teamsRelated responsibilitiesManage essential regulatory documentsRegister study on ClinicalTrials.gov as appropriateComplete case report forms (paper & electronic data capture) and address queriesSubmit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (ie,DSMB, independent safety officer)Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriateFacilitate study close out activities as appropriateCoordinate research/project team meetingsCollect, process and ship samples as applicable to the protocolSchedule subject visits and proceduresRetain records/archive documents after study close out

　　Education QualificationsHigh School Diploma / GED RequiredBachelor's Degree Preferred

　　Experience QualificationsAt least two (2) years of clinical or clinical related or research related experience RequiredAt least three (3) years of clinical or clinical related or research related e perience Preferred

　　Skills and AbilitiesBasic knowledge of IRB and human subject protectionStrong 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.