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Job Summary
Investigators in the Division of Genetics and Genomics at Boston Children's Hospital (BCH) are seeking a full-time research assistant to work on two clinical research projects at the cutting edge of genomic medicine. The projects are synergistic as they both are studies of individualized therapies (genetically targeted experimental medicines) for children with life-threatening ultra-rare genetic conditions. This is an exciting opportunity to work within a multidisciplinary team furthering research and bringing new treatments to rare genetic conditions, and is an ideal position for someone who desires to be at the intersection of cutting-edge research and patient care.

Project 1 - Investigational treatment trials for rare pediatric neurogenetic conditions with individualized antisense oligonucleotides (ASOs):
The goal of Project 1 is to work with the clinical research team to deliver N=1 therapies to patients with rare neurogenetic conditions. These studies involve dose administrations provided in the operating room and various clinical evaluations performed by medical providers.

The Clinical Research Assistant will be responsible for:

• Assisting with protocol and consent development
• Organizing and scheduling study participants for study visits or procedures
• Communicating schedule of study events with research families
• Assisting the PI during patient visits
• Collecting study specimens and delivering or shipping to appropriate locations
• Maintaining regulatory and subject binders, case report forms, and other study documents
• Writing study submissions to the Internal Review Board (IRB) and Data Safety Monitoring Committee (DSMC), including amendments and reportable events
• Maintaining patient sample organization and inventory
• Under supervision, coordinating the activities of daily operations of clinical research studies

Project 2 - Guidance and Ethics for N=1 Interventional Efforts (GENIE):
The goal of Project 2 is to study ethical considerations that arise in such "N=1" trials. This project examines the ethical implications posed by this disruptive new technology through the perspectives of diverse stakeholders (i.e., clinician-scientists, bioethicists, social issues experts, and parents). The aim is to develop a set of recommendations and points to consider that can guide the fair and just implementation of individualized genomic medicine as it evolves.

The Clinical Research Assistant will be responsible for:

• Day-to-day management of the project with PI oversight
• Assisting with literature reviews
• Development and implementation of case materials
• Recruiting and scheduling study participants
• Creating and managing the study databases and documents
• Attending study meetings and taking minutes to distribute to team
• Writing protocol submissions to the Internal Review Board (IRB)
• Overall organization of the project

To qualify, you must have:

• A Bachelor's degree
• Strong communication skills to effectively communicate with families/parents/study participants to explain the study, recruit and schedule, and provide them with accurate information
• Good analytical skills to collect information from diverse sources
• Well-developed writing skills and the ability to work independently are also needed
• Experience with human subject clinical trials is a plus
• Successful candidates will be highly collaborative, passionate about innovative medicine, self-motivated, organized, and have good people skills
• Minimum of a 2-year commitment required

BCH offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.

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