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Senior Research Scientist

Company: Clinical Research Management, Inc.
Location: Silver Spring
Posted on: September 17, 2020

Job Description:

HQ DVBIC

1335 East-West Highway, Ste. 6-100

Silver Spring, MD 20910, USA

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.

Qualifications Education Required

Doctorate or better in Psychology.

Experience Required

Knowledge of the principles and theoretical concepts of outcome from brain injury including neurocognitive and neuro-behavioral effects, treatment, rehabilitation and supportive care requirements. Theoretical understanding of the impact of brain injury on the family caregiver and other family members

Possess general clinical investigation knowledge in TBI and caregivers. Demonstrated ability to oversee a multi-disciplinary clinical investigation team. Ability to develop and implement scientifically sound clinical investigation protocols required.

1 year: Doctoral level degree in Psychology or Public Health required. Training and experience in Health Psychology preferred.

10 years of experience in TBI or other clinical patient care, clinical investigation, education, and/or initiatives. Demonstrated track record in successful development and implementation of clinical investigation projects and dissemination of findings. Demonstrated track record in publishing in peer-reviewed journals and disseminating clinical investigation findings at professional conferences.

Preferred

Knowledge to effectively author professional, peer reviewed journal articles, manuscripts, clinical investigation grant applications, posters and clinical investigation reports required.

Ability to select and apply statistical techniques appropriate to the brain injury clinical investigation protocols under development and/or application is required. Ability to interact with network of clinicians and clinical investigators for sharing new clinical finding developments, CPGs, identifying opportunities and generating new ideas required.

Knowledge of the administrative and regulatory processes appropriate to the above assignments is required. Proven track record of securing grant funding is strongly desirable. Excellent inter-personal and communication skills required. The incumbent must be able to work comfortably with computer software, including Microsoft Word, Excel, Outlook and PowerPoint.

Supervises scientific and administrative staff.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Clinical Research Management, Inc., Silver Spring , Senior Research Scientist, Other , Silver Spring, Maryland

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