Human Subjects Protection Scientist

General Dynamics Information Technology Fort Sam Houston, Texas 78234
JOB ID: 2018-39408 4/9/2018 7:24:39 AM

   

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Job Description

Have you considered a move to the east coast? General Dynamics Information Technology – Health and Civilian Solutions Division is currently looking for a Human Subjects Protection Scientist to join our team to support our client at the Office of Research Protection - MRMC. This position is based in Ft. Detrick – Frederick, Maryland.

The Human Subjects Protection Scientist will:

Provide real-time oversight of USAMRMC-supported research protocols through timely documented reviews of protocol lifecycle actions to assure ongoing compliance

* Provide regulatory-based written review of protocol life cycle actions using standardized checklists.
* Delineate deficiencies and areas of noncompliance and makes recommendations to the HRPO federal AAs regarding regulatory and ethical issues in HRPO post-approval submissions.
* Provide a comprehensive review and evaluation of protocol amendments/addenda
* Provide accurate information, assistance, and documents to customers and HRPO federal personnel when requested with appropriate professionalism in a timely manner.
* Support the HRPO federal personnel in the conduct of noncompliance investigations and compliance inspections of extramural protocols.
* Assist in the preparation of the written report of each compliance inspection
* Provide support for staff assistance visits and HRPP assessments designed to monitor compliance with human subjects protection regulations and make recommendations for improvement.
* Participate in interviews with investigators, study staff, IRB staff, institutional officials, and research participants, and conduct detailed policy and regulatory record reviews, complete staff assistance checklists, and assist with preparation of after-action reports.
* Travel to sites, as needed, to support HRPO federal personnel to provide compliance oversight to USAMRMC-supported research studies.
* Provide support for the HRPO transition from paper to electronic review processes, including implementation and training on electronic review processes.
* Assist the Government to develop policies, procedures, guidelines, and other materials to ensure compliance with current regulations and to update investigators, research managers and administrators, and administrative staff on human subjects protection and regulatory compliance policies and procedures as they apply to research supported by the USAMRMC.
* Assist in the development of local procedures and guidance for the HRPO and the USAMRMC in the area of human subjects’ protection.
* Support the development and implementation of effective mechanisms to communicate and interpret these regulations, policies, and guidelines.
* Assist in development and implementation of internal HRPO operating procedures and review guidelines as requested.
* Foster regulatory compliance through education and training of investigators, research managers, administrators, and HRPO staff
* Acquire and retain knowledge of current Federal, DoD, DA, state, host nation, and USAMRMC regulatory requirements related to the protection of human subjects in research and cadaver use
* Interact with colleagues, consultants, investigators, research directors, supervisors, other US Army personnel, etc., to gather or disseminate information or to provide assistance related to assigned protocols, attend meetings and conference calls as necessary, and provide education on human subjects protection regulations and HRPO requirements.
* Participate in performance improvement activities
Education

* Bachelors Degree in a scientific discipline.

Customer Preferred:

* Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred but not essential
Qualifications

* 2-5 years of related experience in scientific research, analysis and/or engineering.

Customer Preferred:

* Must possess a working knowledge of the Federal regulations governing the protection of human research subjects, including a firm foundation in the Common Rule and FDA regulations, to allow for effective and responsible management of a caseload of research protocols submitted for HQ USAMRMC review and oversight (essential).
* Working knowledge of ethical principles related to participation of humans in research (essential).
* Working knowledge of scientific research concepts and terminology to properly conduct detailed analyses of all research protocols submitted for IRB review.
* Ability to effectively communicate with researchers, research staff and IRB members on matters of research compliance and ethical human research practices.
* Following individual training and guidance, ability to become expert at applying DOD, Army and USAMRMC human subjects protection regulations, policies and guidelines.
* Demonstrated ability to use all components of Microsoft Office and to write clear, precise, detailed, comprehensive and grammatically correct memos and technical reports (absolute requirement).
* Ability to become proficient in the use of an electronic document management system and Oracle-based protocol information management system.
* Excellent organizational skills, professional conduct and businesslike manner, meticulous attention to detail, committed to helping build and sustain team success.

As a trusted systems integrator for more than 50 years, General Dynamics Information Technology provides information technology (IT), systems engineering, professional services and simulation and training to customers in the defense, federal civilian government, health, homeland security, intelligence, state and local government and commercial sectors.With approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support services.GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.

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Security:Secret

Location: Fort Sam Houston, TX - Texas


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