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Clinical Research Coordinator II - Neonatology | Clinical Coordinator, Clinical Research Coordinat1

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Clinical Research Coordinator II - Neonatology

Location:
Philadelphia, PA
Description:

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 Researchers from the University of Pennsylvania and the Children's Hospital of Philadelphia have joined together to support a National Institutes of Health (NIH) program called Environmental influences on Child Health Outcomes (ECHO). This large, observational child health research study began in 2016 to try to answer big questions about how influences in early human development, even before birth, affect us throughout our lives and across generations. The ECHO program is focused on five areas of children's health: pregnancy and birth, breathing, body weight, brain development, and well-being. By enrolling 2500 pregnant individuals and their children from diverse backgrounds (racially, ethnically, and socioeconomically), the Penn-CHOP research team will help contribute to the understanding and enhancement of children for generations to come. More information can be found on our study website: pennchop-echo.org.The ECHO Study Clinical Research Coordinator (CRC) will work closely with the CHOP PIs (Drs. Heather Burris and Sara DeMauro) and be responsible for day-to-day study activities, including scheduling and conducting in-person study visits, obtaining biospecimens, completing data management tasks (including data entry and query resolution), assisting with study retention efforts, and supporting other research-related duties as needed. The ideal candidate is highly organized and motivated, with strong communication and time management skills, and thrives in a team environment. 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 participants 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. EEO / VEVRAA Federal Contractor | Tobacco Statement
Company:
Children's Hospital Of Philadelphia
Industry:
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More About this Listing: Clinical Research Coordinator II - Neonatology
Clinical Research Coordinator II - Neonatology is a Nurse & Healthcare Clinical Coordinator, Clinical Research Coordinator, Research Associate Job at Children's Hospital of Philadelphia located in Philadelphia PA. Find other listings like Clinical Research Coordinator II - Neonatology by searching Oodle for Nurse & Healthcare Clinical Coordinator, Clinical Research Coordinator, Research Associate Jobs.