Research Program Analyst, Safety & Compliance (Neurology)

Johns Hopkins University•Baltimore, MD

3d•Remote

About The Position

We are seeking a Research Program Analyst who will lead a specialized function in a research program that may include data management planning, research design, data driven program evaluation, optimizing funding opportunities and/or other technical duties that contribute to the quality and advancement of the research. 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 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

Requirements

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.

Nice To Haves

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

Responsibilities

Identify research initiatives and inquiries to advance and assess the research priorities of the faculty
Lead research initiatives, e.g. data management activities, program evaluation, internal and external reporting
Contribute to the preparation and writing of reports to funders, manuscripts for publication, and presentations for internal and professional meetings.
Provide and/or contribute to mentoring and training efforts.
Consult with and advise faculty and leadership on systems, policies and practices key to research success.
Other duties as assigned.
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