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The Children's Hospital of Philadelphia Clinical Research Coordinator II - PEDSnet in Philadelphia, Pennsylvania

Reference #: 1009318 SHIFT: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 Overview PEDSnet is seeking a highly motivated Clinical Research Coordinator who will join an internationally recognized group at the Children's Hospital of Philadelphia working to transform the health of children. He or she will work within a dynamic team of researchers, data scientists, and programmers, as part of PEDSnet (, and the Research Institute's Applied Clinical Research Center (ACRC), to understand predictors of childhood diseases, improve the quality of children's healthcare, and rapidly advance knowledge through the creation and development of learning health systems.

The Clinical Research Coordinator will provide administrative and operational support to the Project Management Office (PMO) and Query Fulfillment (QF) team. He or she will work closely with the PMO/QF to oversee Center projects including: 1) Maintaining and organizing study/workflow documentation 2) Utilizing project management tools for tracking project deliverables and timelines 3) Supporting scientific manuscript preparation, presentations, and other project-related activities 4) Responsible for documenting meeting minutes and tracking action items 5) Coordinates meetings across multisite network for project stakeholders 6) Collaborates with physicians, biotechnicians, data scientists, and other study staff members to meet project deadlines and aims

The coordinator must be highly motivated, comfortable working independently and collaboratively, skilled at multi-tasking, and be an effective communicator. Must be able to maintain confidentiality of information, meet deadlines, work on several projects simultaneously, and understand the goals and concepts involved in the work performed. Must be able to establish and maintain a shared work environment and consistently achieve open effective communication with staff and faculty within the Center as well as collaborators at other institutions.

Ideal candidates will have background in network research and or academic research environment. Additionally, candidates with strong drive to grow withing an organization. Experience with Project Management tools such as RedCap, Smartsheet, and Atlassian Products (Confluence and JIRA) highly preferred.

JOB FUNCTIONS Essential Functions Core responsibilities Adhere to an IRB approved protocol Participate in the creation and design of query development workflows Support and coordinate Query Fulfillment activities conducted within the Coordinating Center Screen, recruit and enroll patients/research participants Maintain study source documents Report adverse events Understand good clinical practice (GCP) and regulatory compliance Educate subjects and family on protocol, study intervention, etc. Comply with Institutional policies, standard operating procedures (SOPs) and guidelines Must comply with federal, state, and sponsor policies Monitor and main ain JIRA for query distribution activities Related responsibilities Manage essential regulatory documents Register study on ClinicalTrial.gov Complete case report forms (paper & electronic data capture) and address queries Submit 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 Facilitate study close out activities Coordinate research/project team meetings Collect, process and ship laboratory specimens Schedule subject visits and procedures Retain records/archive documents after study close out Also may be responsible for any of the following: Manage study finances including sponsor invoicing & resolving study subject billing issues Develop advertisement materials Act as liaison for research subject, investigator, IRB, sponsor, and healthcare professionals Document investigational product (drug/device) accountability Self-monitor and self-audit responsibilities Develop informed consent document Maintain Clinical Trial.gov Develop Case Report Forms Assignments to include more complex studies Participate in the informed consent process of study subjects Coordinate protocol related research procedures, study visits, and follow-up care Education Qualifications Bachelor's Degree Required Master's Degree in a related field Preferred Experience Qualifications At least two (2) years of clinical/research coordination experience Required At least three (3) years of clinical/research coordination experience Preferred Skills and Abilities Basic knowledge of IRB and human subject protection Excellent verbal and written communications skills Strong time management skills Ability 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.

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