Reference #: 1008034SHIFT:Day (United States of America)

　　The Division of Rheumatology at the Children's Hospital of Philadelphia is dedicated to improving the safety, quality, and health outcomes of children with rheumatic diseases. Led by Clinical Research Director, Pamela Weiss, MD, MSCE, the Rheumatology Research Core is seeking an experienced Clinical Research Coordinator to work alongside a team of research support staff. This position is full-time. The clinical research coordinator will provide regulatory support for divisional Investigational Drug Application (IND) and Investigational Device Exemption (IDE) studies, day-to-day study management and facilitation of clinical trials, recruitment of patients into clinical research studies, and on-boarding support for team members.

　　Responsibilities:1. Adhere to an IRB approved protocol2. Participate in the informed consent process of study subjects3. Support the safety of clinical research patients/research participants4. Coordinate protocol related research procedures, study visits, and follow-up care5. Screen, recruit and enroll patients/research participants6. Maintain study source documents7. Under the supervision of PI Report adverse events8. Understand good clinical practice (GCP) and regulatory compliance9. Educate subjects and family on protocol, study intervention, etc.10. Comply with Institutional policies, standard operating procedures (SOPs) and guidelines, and with HIPAA and management of confidential materials11. Must comply with federal, state, and sponsor policies12. For multi-site studies or collaborations, support communication and meeting scheduling across teams13. Assist divisional investigators with the development, application, management, and close-out processes of IND & IDE studies by helping with FDA submissions and regulatory oversight

　　Related Responsibilities1. Manage essential regulatory documents2. Register study on ClinicalTrials.gov as appropriate3. Complete case report forms (paper & electronic data capture) and address queries4. Submit documents to regulatory authorities (e.g. IRB, FDA, etc.) and/or review/monitoring boards (i.e., DSMB, independent safety officer)5. Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate6. Facilitate study close out activities as appropriate7. Coordinate research/project team meetings

　　SKILLS AND ABILITIES:Basic knowledge of IRB and human subject protectionStrong verbal and written communication skillsStrong time management skillsAbility to collaborate with stakeholders at all levels

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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.

　　What you will doCore responsibilitiesAdhere to an IRB a proved 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 experience 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.