Clinical Research Coordinator I - Environmental influences on Child Health Outcomes ECHO

Children's Hospital of Philadelphia•Philadelphia, PA

1d•Onsite

About The Position

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. 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.

Requirements

High School Diploma / GED
At least two (2) years of clinical or research related experience
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

Nice To Haves

Bachelor's Degree
At least three (3) years of clinical or research related experience

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, and with HIPAA and management of confidential materials
Comply with federal, state, and sponsor policies
For multi-site studies or collaborations, support communication and meeting scheduling across teams
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