The Social & Behavioral Research Navigator will be responsible to act as a research liaison between those conducting social & behavioral research at Howard Brown Health and the institutional bodies that may be involved in the research approval and conduct process, including but not limited to the Institutional Review Board, Executive Leadership, Grants Round Table, Research Committee, Clinical Research, and clinical staff.
The Research Navigator will serve as an on-site resource for Principal Investigators, Research Staff, and those interested in conducting research at Howard Brown Health. The Navigator will be the first point of contact within the Social & Behavioral Research Program to guide investigators through the administrative start-up and lifecycle of a protocol in collaboration with institutional and external stakeholders.
This individual’s role on each study may differ depending on the study design but will be instrumental in helping to prepare timelines, identifying resources needed for the planning and execution of a project, referring investigators to the appropriate services, and assisting in the IRB submission process.
The Navigator will track areas needing additional support or education and establish, and facilitate appropriate ongoing training opportunities for existing and incoming researchers.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Serves as the liaison for investigators and research staff requesting research support services within Howard Brown Health
- Facilitates Project Kick-Off meeting with investigators to determine resources needs
- Collaborates with Compliance staff to develop and facilitate new and ongoing researcher training
- Conducts Research Project Monitoring to ensure study compliance and uniformity across protocols being conducted at the institution
- Develops feasible study timelines and establishes realistic expectations for study milestones and updates as needed during the lifecycle of the project
- Reviews and provides feedback on operational and regulatory aspects of the study design and protocol and its application at Howard Brown Health specifically
- Advises and assists on initial and subsequent IRB submissions to ensure compliance with FDA Regulations, ICH/GCP, Sponsor’s/Collaborator’s Requirements and Procedures/SOPs
- Provides research staff and PI training as needed
- Aides in the development of study-specific tools such as screening and enrollment logs, regulatory binders, participant binders, electronic maintenance, scripts, templates, etc.
- Travelling between Howard Brown Health sites to meet with investigators and staff at remote sites
- Other duties as determined necessary as the department grows