Reference #: 1012294
SHIFT:Day (United States of America)Seeking Breakthrough MakersChildren'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 InclusionCHOP 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
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 levelsTo 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.EEO / VEVRAA Federal Contractor | Tobacco StatementChildren'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.
