What are the responsibilities and job description for the Clinical Research Coordinator - Neonatology position at Children's Hospital of Philadelphia?
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Day (United States of America)Clinical Research Coordinator I
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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 recruitment and enrollment, scheduling and conducting study visits (both in-person and remote), 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
- Under the supervision of PI 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, and with HIPAA and management of confidential materials
- Must comply with federal, state, and sponsor policies
- For multi-site studies or collaborations, support communication and meeting scheduling across teams
- Related responsibilities
- Manage essential regulatory documents
- Register study on ClinicalTrials.gov as appropriate
- 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 as appropriate
- Facilitate study close out activities as appropriate
- Coordinate research/project team meetings
- Collect, process and ship samples as applicable to the protocol
- Schedule subject visits and procedures
- Retain records/archive documents after study close out
Education Qualifications
- High School Diploma / GED Required
- Bachelor's Degree Preferred
Experience Qualifications
- At least two (2) years of clinical or clinical related or research related experience Required
- At least three (3) years of clinical or clinical related or research related experience Preferred
Skills and Abilities
- Basic knowledge of IRB and human subject protection
- Strong 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
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.
