Clinical Research Coordinator

Clearance Level
None
Category
Research
Location
Silver Spring, Maryland

REQ#: RQ114110

Travel Required: None
Public Trust: NACI (T1)
Requisition Type: Regular

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 Clinical Research Coordinator to support the Operational Research Team (ORT) of 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. The Operational Research Team (ORT) is the premier sleep, circadian, and performance field research team within the Department of Defense. The ORT’s primary objective is to develop, test, and validate field-capable assessments and interventions to both (1) determine the influence of sleep loss and circadian misalignment on Soldier readiness and lethality in the operational environment (e.g. training missions and deployment) and (2) select optimal strategies (e.g. caffeine, blue light, sleep hygiene, sleep banking and recovery) for enhancing Warfighter readiness and lethality

Responsibilities

  • 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.
  • Administer neurocognitive tasks, symptom questionnaires, informed consent, and other related paperwork.
  • 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
  • Proposes, plans, organizes and executes experiments and research.
  • Interacts with other scientists within and outside of the organization.
  • Perform Clinical Research Coordination as directed by the Internal Review Board (IRB), providing protocol coordination, assistance with proposal writing projects, and assistance with progress and technical reports.
  • Organize and prioritize all activities associated with conducting laboratory- and field based human use protocols.
  • Review and understand protocols, ensuring applicable regulations and guidelines are followed.
  • Coordinate with external and internal monitors.
  • Maintain compliance with specific protocol, SOPs, regulations and guidelines.
  • Provide clinical expertise/knowledge to other staff in the department.
  • Monitor volunteer safety, compliance and health status as needed, and follow through with the appropriate physician.

Qualifications:

  • 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 FDA regulatory requirements is required.

About Our Work

We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.

COVID-19 Vaccination

GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.

GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.