Research Program Analyst, Safety & Compliance; Neurology

In addition to the duties described above

• Participate in scientific discussions with collaborators, study teams, and PI
• Collaborate with study teams and PI to ensure operational feasibility of proposed protocol/study design (Risk Assessment)
• Develop or oversee the development of SOP, Data Safety Monitoring Plan (DSMP), Risk Management Plan (RMP) and inform the overall development of the study protocol, case report form (CRF) design, and safety surveillance tables, listings, and figures
• Assist in identifying and evaluating trial risks associated with trial design and operations and the variables that impact the primary efficacy endpoint and critical safety parameters
• Track to completion safety event reviews for multiple clinical trials in real time, assisting with collection of information for assessment adjudication by an independent medical monitor
• Ensure on time reporting of specific safety-related events to the Institutional Review Board (IRB), DSMB, Federal Drug Administration (FDA), and sponsors as determined by the protocol
• Assist in surveilling safety data for the identification of trends and communicate with study teams and study leader
• Collaborate in study operational meetings to review safety and protocol compliance data, engage study teams in evaluating findings, and collectively determine and implement operational improvements

• Master's Degree in a related field.
• Five years of related experience in research focus area.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond a high school diploma/graduation equivalent, to the extent permitted by the JHU equivalency formula.

• Authorship on articles published in peer-reviewed journals.
• Experience writing manuscripts and grants.