Clinical Research Coordinator I - Neuroscience of Driving (NoD) Program

Children’s Hospital of Philadelphia•Philadelphia, PA

About The Position

The Center for Injury Research and Prevention (CIRP) at The Children’s Hospital of Philadelphia (CHOP) is seeking a full time Clinical Research Coordinator (CRC) to support the Neuroscience of Driving (NoD) Program. The Research Coordinator (RC) will support an interdisciplinary team in executing ongoing research projects, working primarily on a large, NIH-funded randomized controlled trial studying how teens learn to drive and testing novel interventions to improve driver safety. This position will be the “face” of the NoD program with CHOP patients & families, recruiting, enrolling, and conducting study visits across CHOP’s network of Primary Care sites, while supporting the Clinical Research Study Lead and Principal Investigator with IRB submissions and providing foundational support in responding to inquires from CRAs and student interns. Key Responsibilities Include: Traveling to CHOP Primary Care Sites and select community locations in and around the Philadelphia area to support recruitment and conduct study visits Screening, consenting, and enrolling study participants Conducting study visits and performing data collection, data cleaning, and basic statistical analyses Providing regulatory and administrative support, including preparing and submitting IRB amendments, continuing reviews, and reportable events to the CHOP IRB Scheduling study activities and maintaining organized study files and task-tracking systems Developing reports and presentations and supporting internal and external reporting needs Assisting with the training, onboarding, and ongoing support of junior-level staff and students The CRC will actively participate in project-related meetings, conduct literature reviews, and may contribute to manuscript development and dissemination activities. Some evening and weekend hours are required to accommodate participant availability, including conducting consent calls, facilitating study visits, and supporting events or presentations. This role requires a high degree of flexibility, including availability for appointments scheduled within 72 hours. Depending on study needs, the individual in this position may work 2–3 days per week conducting offsite study visits at CHOP Primary Care Sites or other local community locations. The position may offer flexibility in start times between 11:00 a.m. and 7:00 p.m., based on study and team needs. Evening responsibilities may include, for example, conducting recruitment and consent phone calls and/or study visits with families between 3:00 p.m. and 7:00 p.m. Additionally, the role requires working at least two Saturdays per month to conduct study visits, typically in 5-hour shifts. This position may also require local travel to CHOP Primary Care Sites, the study’s partner driving school, and other approved community locations to support study operations and assist with troubleshooting technical issues related to the Virtual Driving Assessment (VDA) equipment and software. Applicants with a valid driver’s license and access to a personal vehicle are strongly encouraged to apply. This position is grant-funded and is currently supported for a two-year period, with continuation contingent upon funding availability and programmatic needs.

Requirements

High School Diploma / GED - Required
At least two (2) years of clinical or research related experience - Required
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 - Preferred
At least three (3) years of clinical or research related experience - Preferred

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
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