Clinical Research Coordinator I - HEALthy Brain and Child Development Study (HBCD)

Children's Hospital of Philadelphia•Philadelphia, PA

3d•$53,000 - $66,300

About The Position

The Clinical Research Coordinator I will support CHOP’s HEALthy Brain and Child Development Study (HBCD), a National Institutes of Health-sponsored, long-term study of early brain and child development. CHOP is one of 26 sites in the nationwide study. This is a full-time role involving human-subjects research activities, including participant recruitment and consent, coordination and leadership of in-person visits on CHOP’s campus, data collection and entry across multiple modalities, and administrative work. Additional duties may include home visits, participant retention coordination, and outreach. Experience with MRI, EEG, human specimen collection and processing, and large-scale clinical research is preferred. The role calls for a strong interest and ability to work with families, young children, infants, and pregnant individuals. The coordinator carries out protocol-related research procedures and visits, supports participant safety, maintains study documentation, and helps ensure compliance with good clinical practice, regulatory requirements, institutional policies, and applicable privacy requirements. Other duties include managing regulatory documents, completing case report forms, supporting study monitoring and closeout, coordinating meetings and visits, and collecting and processing samples when required by the protocol. The role requires at least two years of clinical or research-related experience; three years is preferred. A high school diploma or GED is required, and a bachelor’s degree is preferred. Employees with patient-facing responsibilities must receive an annual influenza vaccine as a condition of employment.

Requirements

High school diploma or GED required.
At least two years of clinical or research-related experience required.
Basic knowledge of IRB processes and human-subject protection.
Strong verbal and written communication skills.
Strong time-management skills.
Ability to collaborate with stakeholders at all levels.
Ability and interest in working with families, young children, infants, and pregnant individuals.
Annual influenza vaccination required for employees working in patient-care buildings or with patient-facing responsibilities.

Nice To Haves

Bachelor’s degree preferred.
At least three years of clinical or research-related experience preferred.
Experience with MRI.
Experience with EEG.
Experience with human specimen collection and processing.
Experience with large-scale clinical research projects.

Responsibilities

Adhere to an IRB-approved protocol.
Participate in the informed consent process for study subjects.
Support the safety of clinical research patients and research participants.
Coordinate protocol-related research procedures, study visits, and follow-up care.
Screen, recruit, and enroll patients or research participants.
Maintain study source documents.
Report adverse events under the supervision of the PI.
Understand and follow good clinical practice (GCP) and regulatory compliance requirements.
Educate subjects and families about the protocol and study interventions.
Comply with institutional policies, standard operating procedures, guidelines, HIPAA, and requirements for handling confidential materials.
Comply with applicable federal, state, and sponsor policies.
For multisite studies or collaborations, support communication and meeting scheduling across teams.
Manage essential regulatory documents.
Register studies on ClinicalTrials.gov when appropriate.
Complete paper and electronic case report forms and address queries.
Submit documents to regulatory authorities, such as the IRB or FDA, and to review or monitoring boards, such as the DSMB or an independent safety officer.
Facilitate pre-study, site qualification, study initiation, and monitoring visits as appropriate.
Facilitate study closeout activities as appropriate.
Coordinate research or project team meetings.
Collect, process, and ship samples as applicable to the protocol.
Schedule subject visits and procedures.
Retain records and archive documents after study closeout.
Recruit and consent participants, coordinate and lead in-person study visits on CHOP’s campus, collect and enter data across multiple modalities, and perform administrative tasks.
As needed, conduct home visits, coordinate retention efforts, and conduct participant outreach.