Job Description |
This individual will provide the customer:
- a comprehensive pre-review of research protocols and supporting documents before IRB review by a convened IRB or via expedited review procedure;
- post-IRB approval lifecycle management of assigned research protocols, including pre-review of amendments, continuation reports, reports of unanticipated problems/serious adverse events/serious or continuing noncompliance/ research suspension or termination /protocol deviations, and final study reports
- support for site visits (monitoring, non-compliance) to include preparation and planning visits, assisting during visits, and preparing written reports
- assistance in the development and updating of the IRBs human subjects protection polies, procedures, guidelines, and process improvement initiatives
- assistance in developing human subjects protection education and training programs
- assist in the IRB's internal quality control/assurance program
- support for the Human Research Protections Office, as needed, to include conducting DoD-required headquarters-level administrative human subjects protection regulatory reviews for USAMRMC-supported research and DoD-conducted research. The individual will work on Ft. Detrick as a member of a team comprised of military, government civil service and contract employees.
1. Bachelors Degree in a scientific discipline.
2. Masters Degree preferred.
- 5-8 years of related experience in scientific research, analysis and/or engineering.
- Minimum 2 years of experience as an IRB office staff member
- Current training in humans subjects protection.
- Certified IRB Professional (CIP) or Certified IRB Manager (CIM) preferred
- Must possess a firm foundation in Federal regulations and ethical principles governing the protection of human research subjects, including the Common Rule and Food and Drug Administration regulations, so as to provide the customer with accurate and complete written pre-reviews of research protocols and life cycle event (absolute requirement).
- Knowledge of research concepts to facilitate a detailed review of all types of research protocols submitted for IRB review (essential).
- Following on-the-job training, ability to proficiently apply DOD, Army and USAMRMC human subjects protection regulations, policies and guidelines (absolute requirement).
- Ability to quickly become proficient in us of an on-line document management system and an Oracle-based protocol information management system to include ensuring data in protocol information management system is current and accurate (absolute requirement).
- Ability to effectively communicate with researchers, research staff and IRB members on matters of research compliance and ethical human research practices (essential).
- Ability to write clear, precise, concise, and grammatically correct emails, memos and technical reports (absolute requirement)
- Must possess excellent organizational skills and meticulous attention to detail (essential).
- Must be flexible and able to prioritize workload to meet the needs of the customer while effectively managing assigned portfolio of research protocols (essential).
- Proficient in use of Microsoft Word, Outlook, and Excel (absolute requirement).
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 NA approximately 32,000 professionals worldwide, the company delivers IT enterprise solutions, manages large-scale, mission-critical IT programs and provides mission support NA is an Equal Opportunity/Affirmative Action Employer - Minorities/Females/Protected Veterans/Individuals with Disabilities.