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Senior Research Scientist/Director

Company: Clinical Research Management
Location: Silver Spring
Posted on: June 6, 2021

Job Description:

ICON Government and Public Health specializes in preclinical through phase IV support of clinical research and clinical trial services for biologics, drugs, and devices. We help our customers get their products to market faster with a wide array of research, regulatory, and sponsor services both within the US and around the globe and respond rapidly to global health crises.

Position Summary:

Through DVBIC government oversight s/he will be responsible for providing scientific and academic guidance for a program of clinical investigation focusing on long terms effects of traumatic brain injury (TBI) within the Defense and Veterans Brain Injury Center (DVBIC). S/he will provide scientific expertise and guidance to the congressionally mandated 15-Year Longitudinal Studies. S/he will consult with and assist other groups in the development and implementation of TBI related clinical investigations as needed.

Essential functions:

Reasonable Accommodation Statement:

To accomplish this job successfully, an individual must be able to perform, with or without reasonable accommodation, each essential function satisfactorily. Reasonable accommodations may be made to help enable qualified individuals with disabilities to perform the essential functions.

  • Provides scientific leadership and expertise related to the execution of the 15-Year Longitudinal Studies and maintains knowledge of TBI longitudinal research work. Oversees all aspects of research execution, management, maintenance of 15 Year research studies, build collaborations/partnerships in lieu of 15 Year research studies. May serve as Investigator on DVBIC clinical research studies.
  • Provides scientific leadership for all aspects of a 15 Year clinical research investigation project including concept development, protocol design, form development, oversees submission through regulatory bodies, data collection and analysis, production of professional manuscripts for journal submission and professional presentations.
  • Follows guidelines and DVBIC leadership guidance to support this large project with knowledge of general directives established by and with the Principle Investigator.
  • Serves as points of contact for communication related to the 15 Year Studies and ensures that all required documents and procedures are performed within established guidelines.
  • Provides required reports, status of regulatory compliance of the studies and meets scheduled report submission requirements.
  • Coordinates, oversees, monitors and day-to-day operations over Project activities.
  • Ensures scientific quality and progression of the Project meeting milestones as targeted.
  • Assigns mission appropriate contract staff or contract support personnel for the Project.
  • Ensures that realistic deadlines are set and appropriate resources are assigned to accomplish all established tasks.
  • Monitors and reports on the progress of 15 Year studies to ensure that all critical elements are proceeding on schedule and that all deliverables are provided on a timely basis.
  • As authorized by DVBIC, may represent the PI at meetings or other interactions.
  • Communicates with and oversee collaborations with academic institutions and external authorities.
  • Oversees each contractor Project element receives the necessary attention to meet all milestones.
  • Provides scientific review of prospective contractor personnel's history regarding scientific personnel recruitment.
  • Prepares requests for actions/proposals to include assisting with grant proposal applications, their associated documentations and requirements. Facilitates the flow and approval processes for other projects as needed or requested.
  • In collaboration with DVBIC leadership and study investigators, provides assistance and expertise to DVBIC leadership in responding to "taskers", drafting of EXSUMS and Information Papers, associated reports to congress and attendance at required meetings related to the 15 Year research studies.

WORKING CONDITIONS/PHYSICAL DEMANDS:

Work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. May encounter patients who are confused, agitated, or abusive.

WORK ENVIRONMENT:

Laboratory/office environment; may require working evenings and weekends. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to manipulate objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; talk or hear. Work may involve long periods of standing and handling of numerous chemicals and/or hazardous biological material. The employee must occasionally lift and/or move up to 25 pounds. The noise level in the work environment is usually moderate.

Keywords: Clinical Research Management, Silver Spring , Senior Research Scientist/Director, Other , Silver Spring, Maryland

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