Job Details
Clinical Study Support Scientist
Location MD - Fort Detrick
Job Code 11575
# of openings 1
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The Alaka`ina Foundation Family of Companies (FOCs) is looking for a qualified Clinical Study Support Scientist to provide support services for our government customer, in a high containment facility, in Fort Detrick, Maryland.
In addition to the proposed salary, the selected candidate will receive a one (1) time sign-on bonus in the amount of $2,000.00.
DESCRIPTION OF RESPONSIBILITIES:
+ Provide support for clinical studies with focus on exploration of existing and development of new diagnostic, clinical and research assays for emerging and high consequence pathogens, including assay testing, validation, qualification, and verification.
+ Assist in development of a clinical study assay preparedness plan.
+ Provide support and training in assay deployment, training, and execution in domestic and international locations.
+ Maintain strong collaborations and communications with vendors and industry with focus on assays in support of clinical trials.
+ Develop and maintain processes for assay regulatory compliance for clinical trial support.
+ Deploy to international locations for up to six months (cumulative up to three months) per year to provide laboratory support and laboratory capability development for clinical trials, research studies, and outbreak preparedness/response activities.
+ Provide laboratory support for studies, which may include screening of medical countermeasures for efficacy in vitro and in vivo but may extend to disciplines related to virology.
+ Generate high quality interim and final study reports and develop them for timely publication in peer-reviewed journals.
+ Actively participate in practices/processes to enhance data quality and integrity including periodic review of study execution to identify gaps and refine procedures.
+ Develop and implement training and cross-training programs to assure continuity of operations and scientific core activities.
+ Develop and revise Standard Operating Procedures and methods for laboratory operations.
+ Comply with the NIH Division of Occupational Health and Safety requirement for satisfactory completion of the Biosurety program and Select Agent program.
+ Play a role in ensuring that the Biosurety program promotes a security conscious culture.
+ Must be able to deploy to international locations for up to six months (cumulative up to three months) per year to provide laboratory support and laboratory capability development for clinical trials, research studies, and outbreak preparedness/response activities.
+ Comply with the physical security, protection of the divisions property, protection of information, cyber security, select agent protection, control and accountability, safe disposal and waste handling, and personal security guidelines set forth by the divisions Biosurety program.
+ Other duties as assigned by Supervisor.
REQUIRED DEGREE/EDUCATION/CERTIFICATION:
Masters level degree highly preferred in biological sciences with four (4) years of relevant experience or baccalaureate level degree in biological sciences with eight (8) years of relevant experience.
REQUIRED SKILLS AND EXPERIENCE:
+ Must have professional experience in virology, molecular biology, immunology, and/or public health.
+ Must have four (4) years of specialized training in research.
+ Must have experience with diagnostic, clinical and immunological including but not limited to ELISA, multiplex immune assays such as Luminex, Quanterix or MSD, qRT-PCR, cell culture, piccolo tests, etc.
+ Must be able to maintain inventory, write SOPs, provide technical review, maintain instruments and instrument logs.
+ Knowledge and experience of Good Laboratory Practices and other regulations governing the clinical research and understanding of RUO, EUA and FDA approved assays.
+ Ability to obtain/maintain DOJ Security Risk Assessment approval.
+ Must be able to deploy to international locations for up to six months (cumulative up to three months) per year to provide laboratory support and laboratory capability development for clinical trials, research studies, and outbreak preparedness/response activities.
+ Must be willing to be immunized with licensed and FDA approved Investigational New Drugs recommended for persons at risk for occupational exposure to biological agents.
+ Must be willing to participate in periodic drug screening.
+ Must have the ability to obtain/maintain certification in Chemical Personnel Reliability Program and/or Biological Personnel Reliability Program.
+ Must have the ability to obtain/maintain CDC Select Agent Program approval.
+ Ability to work under BSL-4 conditions.
+ Able to wear respiratory protection.
DESIRED SKILLS AND EXPERIENCE:
+ Previous experience working in a BSL-4 environment.
+ Experience with viral Select Agents.
+ Previous international field research experience in virology, immunology, molecular biology or public health.
+ Familiarity with use of clinical laboratory instrumentation, testing and standards.
+ Good Clinical Laboratory Practice experience is preferred.
+ Proficiency in Word, Excel, and PowerPoint
REQUIRED CITIZENSHIP AND CLEARANCE:
+ Must be a U.S. Citizen
+ Must be able to meet the requirements for Individual must be able to meet the requirements for T3 level investigation.
The Alaka`ina Foundation Family of Companies (FOCs) is a fast-growing government service provider. Employees enjoy competitive salaries; a 401K plan with company match; medical, dental, disability, and life insurance coverage; tuition reimbursement; paid time off; and 11 paid holidays. Laulima Government Solutions, LLC is proud to be an equal opportunity employer.
We are an Equal Opportunity/Affirmative Action Employer of individuals with disabilities and veterans. We are proud to state that we do not discriminate in employment decisions based on race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. If you are a person with a disability and you need an accommodation during the application process, please click here (...@alakaina.com?subject=Request for accommodation.) to request accommodation. We E-Verify all employees.
The Alaka`ina Foundation Family of Companies (FOCs) is comprised of industry-recognized government service firms designated as Native Hawaiian Organization (NHO)-owned and 8(a) certified businesses. The Family of Companies (FOCs) includes Ke`aki Technologies, Laulima Government Solutions, K?pono Government Services, and Kapili Services, Po`okela Solutions, K?kaha Solutions, LLC, and Pololei Solutions, LLC. Alaka`ina Foundation activities under the 501(c)3 principally benefit the youth of Hawaii through charitable efforts which includes providing innovative educational programs that combine leadership, science & technology, and environmental stewardship.
For additional information, please visit www.alakainafoundation.com
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