The Walter Reed Army Institute of Research (WRAIR) aims to conduct biomedical research that is responsive to Department of Defense (DOD) and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter. Our team is seeking technical expertise to provide support to WRAIR’s Center for Military Psychiatry and Neuroscience Research (CMPN) CMPN is a translational and expeditionary effort to identify and eliminate brain health threats to Soldiers. CMPN investigates and manipulates the relationship between sleep and performance, performs behavioral health assessments to inform unit Commanders on Soldier behavioral health needs, and develops and implements resilience trainings. On a parallel track are efforts to identify and treat traumatic brain injury as well as understand the impact of repeated blast exposure.
Specifically, our team is seeking a Sleep Laboratory Manager to support the Behavioral Biology Branch within CMPN. The Behavioral Biology Branch aims to develop knowledge products and materiel solutions to enhance Soldier alertness, decision-making, and performance in the context of degraded sleep quantity and quality across the spectrum of Army operations.
Develop and maintain Standard Operating Procedures for data collection, and ensure that all study data are collected, recorded, documented, and archived in compliance with Good Clinical Practices and pertinent government rules, regulations, and policies.
Administer psychological and performance measures to subjects as specified in protocols.
Maintain an appropriate, professional demeanor in all interactions with human research participants and research collaborators.
Oversee recruitment and screening of volunteers for human research protocols.
Assist in Subject recruitment physicals, including administration of standardized psychological evaluations.
Responsible for a number of sleep studies to include, pre-site visit preparations, as well as site visit responsibilities and travel/overnight stays for up to studies (5) studies.
Conduct site visits as dictated by the monitoring plan, focusing on: subject entry criteria, informed consent process, and verification of data accuracy and protocol/study compliance.
Communicate with site Investigator/coordinator any issues, including adverse effects, that require
Assumes lead role in various research and development activities.
Proposes, plans, organizes and executes experiments and research.
Utilizes established mathematical and scientific techniques to compile and analyze data.
Summarizes findings in reports and communicates results.
Interacts with other scientists within and outside of the organization.
Requires a BS, RN, or BSN degree or equivalent and a minimum of 5 years of experience in the field or in a related area.
Knowledge of/experience with FDA regulations, rules, and policies affecting conduct, record-keeping, and monitoring of human protocols involving investigational new drugs.
Ability to teach these practices to others (students, enlisted soldiers, etc.) as appropriate, and to monitor study data collection procedures to ensure uniformly high levels of compliance with FDA-required practices throughout all phases of the study: preparation, conduct, analysis, and archiving of clinical data.
Oversee technical and logistical aspects of the conduct of human research in the fields of: sleep, sleep deprivation, electroencephalography, psychophysiology, and others—and aids in the statistical analyses, presentation, and publication of resulting data sets – to include assisting in the preparation of any progress and/or final reports to the FDA and/or commercial (e.g., pharmaceutical industry) sponsors of IND research.
Knowledge of ICH/GCP and FDA/CFR guidelines for pharmacological agents used in human use research or past related experience showing the ability to master similar skills is a critical requirement.
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