Senior Research Scientist

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:

S/he will provide scientific management and guidance to government regarding congressionally mandated 15-year longitudinal studies, the multi-phase epidemiological studies that considers diverse psychosocial and neurobiological risk and protective factors for outcome from traumatic brain injury in service members and the effect on family members. S/he will consult with and assist other groups in the development and implementation of TBI related health programs.

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 direction and oversight for the 15-Year Longitudinal studies, with particular focus on service members in the community their caregivers and family members. May serve as Investigator on DVBIC clinical research studies.
• Provides scientific oversight for all aspects of a large clinical investigation project including study concept development, protocol design, form development, submission through regulatory bodies, data collection and analysis, production of professional manuscripts for journal submission and professional presentations.
• As authorized by DVBIC, consults and assists other groups in the development and implementation of TBI related health programs in support of DVBIC's mission.
• Documents findings and recommendations in clinical investigation reports, peer-reviewed publications and conference presentations.
• Ensures clinical investigation project activities and records are in compliance with study, IRB and organizational requirements. Ensures that data and paperwork is properly stored/maintained according to regulations.
• 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 for the Program, receiving support requests and ensuring that all required documents and procedures are performed within established guidelines.
• Coordinates, oversees, monitors and have day-to-day direction over Project activities.
• Ensures scientific quality and progression of the Project meeting milestones as targeted.
• Assigns responsibilities appropriate for contract staff or contract support personnel related to the 15 Year studies.
• May be called upon to represent the PI at meetings or other professional interactions.
• Communicates with and oversee collaborations regarding the 15 Year Studies with academic institutions and other external authorities.
• Provides scientific review of prospective 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, Other , Silver Spring, Maryland