Clinical Research Coordinator I- Radiology, Brains Change
About The Position
The Brains Change team conducts a wide range of neuroimaging studies related to brain function and structure in typically developing infants as well as preschool children born premature. We are seeking to understand brain development from birth to early childhood. Recruited participants include infants, toddlers, and preschool children. We are seeking a full-time Clinical Research Coordinator (CRC) to help manage our infant and preschool children brain imaging studies. This individual will work closely with the team of principal investigators, psychologists, post docs, research coordinators and research assistants and imaging techs. The CRC will help recruit study participants for brain imaging visits, creating and maintaining study regulatory binder and REDCap databases, prepare and update study IRB paperwork, subject management including supporting children and families through their research study participation (oversee informed consent, screening, compensation, and billing). The CRC will have regular contact with typically developing and neurodivergent populations and their families. Prior experience with some or all of these duties (especially prior experience managing a REDCap database, IRB, and study regulatory binders) is a plus; as are excellent problem identification and problem solving skills for the team. Successful applicants will be highly self-motivated and fast learners who enjoy working in a bustling clinical research environment.
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
- Prior experience managing a REDCap database, IRB, and study regulatory binders is a plus
- Excellent problem identification and problem solving skills
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
Benefits
- Annual influenza vaccine
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
