Inside Higher Ed · 5 hours ago
Research Program Analyst, Safety & Compliance (Neurology)
United States
Full-time
Remote
Senior Level
$65K/yr - $113K/yr
5+ years expInside Higher Ed is seeking a Research Program Analyst specializing in Safety & Compliance within the Neurology department. The role involves collaborating with study teams to ensure operational feasibility, developing safety protocols, and monitoring compliance throughout the clinical trial lifecycle.
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Responsibilities
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
Monitor activities, systems, and processes specific to safety-related events and protocol compliance through the clinical trial lifecycle, including but not limited to, 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
Qualification
Required
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
Preferred
Authorship on articles published in peer-reviewed journals
Experience writing manuscripts and grants
Company
Inside Higher Ed
Inside Higher Ed is the online source for news, opinion, and jobs related to higher education.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2022-01-10Acquired
2006-08-31Series Unknown
Leadership Team
Stephanie Shweiki
Director, Foundation Partnerships
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