The Geneva Foundation

Regulatory Affairs Assistant

Req No.
2022-3251
Category
Office of Research Management (ORM)
Type
Regular Full-Time
Job Locations
US
<b> Location : Name </b>
Remote/Telework

Overview

About The Geneva Foundation

 

The Geneva Foundation is a 501(c)3 nonprofit established in 1993 with the purpose to ensure optimal health for service members and the communities they serve. This purpose is accomplished through our mission to advance military medicine through research, development, and education. Our vision is to lead the way in transforming military medicine. Our culture is living our core values that focus on a higher purpose. Geneva serves a diverse population and is committed to making diversity, equity, inclusion and belonging a central focus of the employee experience. As a leader in military medical research, we develop critical lifesaving solutions for the global community and build rewarding careers for our employees.

 

Benefits

 

Our benefits package includes financial rewards that are a significant part of the employee's total rewards compensation package. Geneva's highly competitive benefits include medical, dental, and vision healthcare, Flexible Spending Account, Health Savings account, with employer contribution. Coverage is provided for employees and family members including domestic partners. Short-and long-term disability, Employee Assistance Program, Life & ADD insurance, 403b retirement plan with generous employer match, flexible leave options, 11 paid holidays per year, and up to 4 weeks of paid time off in a rolling year. Employees may qualify for PSLF as Geneva is a 501(c)(3) nonprofit organization. Full time positions come with all benefits. Part time and intermittent positions may vary.

 

About The Position

 

The Regulatory Affairs Coordinator maintains regulatory documents related to research, serves as principal administration regulatory liaison for projects, develops and maintains recordkeeping systems and procedures, supervises and prepares documents which support research projects, submits and manages IRB application documents, collate appropriate trainings, and provide regulatory audit support.

 

About The Project

 

The Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) was established to support the execution of clinically relevant research to advance the care of service members with non-combat related musculoskeletal injury (MSI). Headquartered at the Uniformed Services University of the Health Sciences (USU), MIRROR provides coordination and support of inter-service and inter-disciplinary partnerships across military treatment facilities (MTFs), military training centers (MTCs), and civilian academic centers to execute cutting-edge research in order to mitigate the burden of MSI on military readiness. 

 

Salary Range

 

$50,000 - $55,000. Salaries are determined based on several factors including external market data, internal equity, and the candidate’s related knowledge, skills, and abilities for the position.

Responsibilities

 

  • Create and maintain electronic regulatory binders and files of all applicable regulatory documentation (including approval letters, protocols, submissions, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.)
  • Maintain study team Curriculum Vitae (CV), Conflict of Interest (COI) Forms, trainings completion reports, and licenses as required
  • Assist with the preparation of regulatory documents to support Institutional Review Board (IRB) submissions (initial, modifications, continuing reviews, closeouts, etc.)
  • Utilize electronic IRB system to upload and manage study documents, as needed
  • Track and report program-wide subject accrual, adverse events, protocol deviations, etc.
  • Prepare and maintain minutes for regulatory-related calls/meetings, as needed
  • Provide administrative support to program regulatory team, as needed
  • Promote safety and confidentiality of research participants at all times
  • Stay up-to-date in all relevant research training

Qualifications

  • Bachelor’s degree or equivalent work experience required
  • 2-4 years of experience in healthcare administration or clinical research required
  • Regulatory and IRB submission experience preferred
  • DoD research process and procedural knowledge preferred
  • Demonstrated competence in oral and written communication
  • Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor
  • Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner
  • Ability to exercise independent judgment in fast-paced, high-pressured environment with strict deadlines and to manage multiple projects
  • Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software

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