Clinical Research Coordinator I - Neurology
About The Position
A Clinical Research Coordinator I position is available within the pediatric neurology research program focused on studies of Neurodevelopmental Disorders and Epilepsy in children. The goal of this research program is to advance understanding of neurological development and seizure disorders through clinical research studies that examine developmental outcomes, and potential therapeutic interventions in pediatric populations. The candidate will be a member of the research team and will support the coordination and implementation of clinical research studies under the supervision of investigators and senior research staff. Responsibilities include assisting with participant recruitment and consent, coordinating study visits, maintaining regulatory and study documentation, collecting and entering research data, and interfacing with clinical teams and investigators to facilitate study activities. All research activities will be conducted in accordance with study protocols, institutional policies, and Good Clinical Practice (GCP) guidelines. The position requires an individual who is comfortable working with pediatric patients and families and who demonstrates strong communication skills, organizational abilities, and meticulous attention to detail.
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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
