Clinical Research Coordinator - Sleep in Preschoolers (SIPS)

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.