Research Navigator (Neurology)

Johns Hopkins University•Baltimore, MD

5d•Remote

About The Position

The Department of Neurology is seeking a Research Navigator to support and coordinate work across more than 20 clinical sites nationwide. In this role, you’ll join a collaborative, high performing team dedicated to advancing and improving multi-site translational research. The Research Navigator works with investigators on project evaluation, trial simulation, and planning activities. Applies clinical trial design expertise and regulatory experience in working with IRBs, master/standard agreements and various grant mechanisms and funding agencies. The Research Navigator will have or develop a thorough knowledge and understanding of all programs and resources within the consult/grant mechanisms available to assist research teams. Will function as a liaison for inquiries related to receiving consult/grant support. Will work with leadership to identify problems and implement initiatives to ensure that timely and useful research support from the various consult/grant programs is provided to investigators.

Requirements

Bachelor’s Degree in a related field.
Five years of experience in clinical research in an academic, government or pharmaceutical industry environment.
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.
Attention to Detail - Intermediate
Clinical Research Knowledge - Intermediate
Clinical Study Design - Intermediate
Clinical Trials - Intermediate
Good Clinical Practices - Intermediate
Oral and Written Communications - Intermediate
Organizational Skills - Intermediate
Project Management - Intermediate
Research and Analytical Skills - Intermediate

Nice To Haves

Master’s Degree in a related field.
Certification as a Clinical Research Professional.

Responsibilities

Manage all aspects of the protocol optimization process: assembling project plans, team, and work assignments, directing and monitoring work efforts, identifying resource needs, performing quality review, and escalating functional, quality and timeline issues appropriately.
Manage investigator relationships.
Assist or serve as the consultation lead to determine with investigators the priority discussion topics to address during the consultation and organize the panel of expert consultants to accommodate the specific needs of each project.
Track consultations and resulting documentation through signature/approval processes and disseminate as appropriate.
Execute project management processes and methodologies to ensure consultations are completed on time, adhere to high quality standards, and benefit the investigative teams by ensuring a well-prepared grant application or smooth implementation of consult/grant services.
Serve as liaison and facilitate meetings between project stakeholders and leadership and complete and maintain professional documentation for projects and deliverables, develop Standard Operating Procedures as needed, assist in the auditing and monitoring of established workflows and processes.
Use professional judgment in handling information and be sensitive to project team, individual and all levels of organizational concerns.
Make use of data, statistical and quantitative analysis, explanatory and predictive modeling, and fact-based management to drive decision making.
Help investigators develop new insights and understanding of performance-based data during the consultation and grant production processes.
Other duties as assigned.
Single-IRB (sIRB) coordination & regulatory submissions: preparing sIRB regulatory packets and compiling local context for initial/continuing review and reportable events for JHM sIRB.
Training participating site leads on sIRB procedures: designing and delivering guidance to 20+ sites to meet sIRB expectations and timelines.
Drafting informed consent documents: creating consent forms aligned with protocol and IRB requirements.
SOP development and process improvement for sIRB operations: building SOPs and refining workflows in collaboration with JHM sIRB leads to reduce approval delays.
Data-driven decision-making using statistical/predictive modeling: applying quantitative analysis to help investigators interpret performance data and drive decisions.