"Clinical Research Assistant-National Brain Gene Registry (BGR)"

Position Summary:

The National Brain Gene Registry (BGR) is a collaborative initiative aimed toward better understanding the impact of rare gene variants in individuals with intellectual and developmental disabilities, with the vision of improving the lives of individuals and families touched by these conditions. Conducted across multiple sites in the Unites States, the BGR protocol includes collection of genetic and medical history data from participants, as well as a rapid neurobehavioral assessment. Under the supervision of the Principal Investigator and Program Manager, the Brain Gene Registry (BGR) Clinical Research Assistant will coordinate and carry out daily activities and operations of the BGR at the Boston Children's Hospital site.

The BGR Clinical Research Assistant will work closely with the BCH Neurology Department genetic counselors to identify patients eligible for the BGR. The Clinical Research Assistant will be responsible for screening, consenting and enrolling participants, collecting medical and genetic testing records, and facilitating collection of neurobehavioral assessments. They will also be responsible for data entry and completing required research documentation. The Clinical Research Assistant will assist with Institutional Review Board submissions and preparation of reports regarding study results and enrolment metrics. The Clinical Research Assistant will follow established clinical study standards and procedures for research involving human subjects. They will maintain open communication with team members to ensure proper study progress.

Key Responsibilities:

• Consents and enrolls patients for research studies by providing detailed information on the Research Study to patients and families. Is responsible for understanding and adhering to all policies and procedures and responds to all inquiries. Obtains informed consent and enrolls patients in research studies. Reviews clinical information to identify patients meeting study inclusion criteria.
• Serves as liaison to the families/patients in the research studies, conducted at both on site and off-site locations, guiding and advising them throughout each phase of the study. Coordinates follow up visits as necessary. Acts as a resource to study participants, addressing any concerns they may have. Troubleshoots resolution of any issues that may arise throughout the study.
• Coordinates and prepares documentation needed for Institutional Review Board (IRB) on submissions, for PI approval. Tracks progress from submission to approval.
• Assist in developing supportive study documents such as informed consent forms, monitoring templates, study subject tracking tools, monitoring forms, study manuals, and training materials, as required for a study. Assist with the tracking and compilation of enrollment information.
• May assist with preparation of manuscripts and reports to be submitted to academic journals.
• May help train and orient newly hired study personnel.
• Coordinates activities with various departments to ensure correct testing/processing and sends clear instructions to each study. Monitors and reviews data collection and data entry, and informed consent procedures ensuring consistency of application for each study.

Minimum Qualifications

Education:

• Bachelor's Degree Required + Preferred degree in Biology, Psychology, Neuroscience, or related fields.

Experience:

• Experience with individuals with neurodevelopmental disabilities preferred.