"Clinical Research Assistant-The Neuromuscular Program"

Department Summary

The neuromuscular program is part of the Neurology Department at Boston Children's Hospital. Our team is comprised of 7 CRAs (Clinical Research Assistant) & CRCs (Clinical Research Coordinators) working under 4 researchers (Basil Darras, MD, Partha Ghosh, MD, Leslie Hayes, MD, and Regina Laine, NP) with over 30 ongoing clinical trials. Most trials are sponsor funded-investigational drug trials and involve patients with SMA (Spinal Muscular Atrophy), DMD (Duchenne Muscular Dystrophy). As a CRA you would be responsible for facilitating and coordinating the trials on a day-to-day basis. Teamwork, organization, adaptability, and creativity are extremely important for any candidate. This role is looking for someone to start ASAP and a two-year time commitment is preferred.

Key Responsibilities

• Working with Principal Investigators (PIs) to facilitate and coordinate the everyday activities of assigned clinical trials including, scheduling patient visits with many different departments e.g. Physical Therapy, Radiology, Anesthesia.
• Attending and organizing all study visits with the participant and family.
• Monitoring for Adverse Events with study participants, and reporting them to the PI, IRB and sponsor in a timely manner.
• Facilitating communication between the PI and the patients.
• Maintaining study protocol documents for applications or amendments to the IRB.
• Ensuring that all staff involved in the study have been trained properly.
• Coordinating with study sponsors and monitors to ensure compliance with the protocol and reporting protocol deviations.
• Maintenance of regulatory binders, Case Report Forms, Visit Order forms and other study related documentation. Ensuring patients are reimbursed for their visits.
• Recruiting, screening and consenting patients to studies.
• Data entry and resolution to data entry queries.

Minimum Qualifications

Education:

A Bachelor's Degree in STEM or Psychology is required.

Experience:

None required