Senior Research Scientist/Director
Company: Clinical Research Management
Location: Silver Spring
Posted on: June 6, 2021
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.
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
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
- 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
- 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
- Coordinates, oversees, monitors and day-to-day operations over
- 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
- 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
- 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.
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
Didn't find what you're looking for? Search again!