Reference #: 1012294 SHIFT:Day (United States of America)

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A Brief Overview Under minimal supervision, this role substantially coordinates all clinical research activities within the scope of clinical research protocols.

The Sleep in Preschoolers Study (SIPS) is seeking a full-time clinical research coordinator to oversee study activities for a project on early childhood sleep health disparities that is funded by the National Heart, Lung, and Blood Institute (NHLBI). The study aims to better understand factors related to the child, family, preschool, and neighborhood environment that can be modified to help prevent racial disparities in pediatric sleep disordered breathing, insufficient sleep, and neurobehavioral outcomes. Data collection includes actigraphy (accelerometer-based sleep measurement), an overnight sleep study (polysomnogram), caregiver questionnaires, preschool teacher questionnaires, caregiver-child interaction tasks, child tasks, and child laboratory samples (blood and saliva). This project is in the third year of a five-year award.

Clinical research coordinator responsibilities include: Oversight and adherence to the IRB-approved protocol, with continuing reviews submitted every 6 months; participant recruitment, consent, and data collection; educate participants on study procedures and act as their "point of contact" throughout their participation for questions or study-related concerns; coordinate research procedures and schedule in-person study visits with participants, the CHOP Sleep Lab, and the nursing/CHPS lab core; oversee actigraphy device configuration, data collection, scoring, and participant tracking; maintenance of study documents and participant survey responses in study-specific REDCap databases and other platforms (e.g., PariConnect); coordinate team meetings and keep minutes during meetings; manage study materials and order supplies as needed; act as liaison between the study team and internal offices at CHOP (IRB, Office of Research Compliance, Recruitment and Enhancement Core); supervision of research assistants. Opportunities are available for engagement in data analysis and scholarly writing (i.e., conference abstracts and peer-reviewed publications). This position requires on-site data collection at the Roberts Center for Pediatric Research and the main hospital at least 3 days per week. Off-site/hybrid work is possible 1-2 days per week. Evening hours (5-7pm) and early morning hours (7-8am) are needed for participant data collection, although other study team members may be available to assist with data collection at these times.

Duties involve managing the day-to-day activities of the research study under the guidance of PI or managing study staff.

What you will do Core responsibilities Adhere to an IRB approved protocol Participate in the informed consent process of study subjects Support the safety of clinical research patients/research part cipants Coordinate protocol related research procedures, study visits, and follow-up care 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 Related 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 role Register study on ClinicalTrial.gov as appropriate Complete case report forms (paper & electronic data capture) and address queries Facilitate pre-study, site qualification, study initiation, and monitoring visit as appropriate Facilitate study close out activities as appropriate Coordinate research/project team meetings Collect, process and ship laboratory specimens Schedule subject visits and procedures Retain records/archive documents after study close out Additional Responsibilities may include 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 Organize and/or run study-related meetings locally or across teams (for multi-site projects) Support study team communications and outreach Provide training to junior staff on conduct of research studies Document investigational product (drug/device) accountability Self-monitor and self-audit responsibilities Develop informed consent document and/or draft or edit IRB protocols or related documents such as study administration manuals Maintain Clinical Trial.gov Develop Case Report Forms Assignments to include more complex studies 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. Learn more.

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.