Job opening ID
Roles and responsibilities
Must be authorized to work in the United States
Some travel may be required
Offer contingent on ability to successfully pass a background check and drug screen
Columbus Technologies and Services Inc. is a strategic supplier and business partner to the federal government and its key suppliers. Through our partnership with the National Institutes of Health, Columbus offers administrative, IT, engineering, scientific, and healthcare professionals the opportunity to work with one of the most prestigious research organizations in the world. We are currently seeking Management Analyst to work onsite with the National Institutes of Health in MD.
This is a long-term position which offers:
- Competitive salary
- Tremendous growth opportunity
- Opportunity to work at NIH, the world's foremost medical research center
- Learn more about what Columbus can do for you at www.columbususa.com
The contractor shall:
• Develop and maintain/modify SOPs for the management of the AoURP’s FDA-approved IDE including development and implementation of template documents.
• Coordinate with the AoURP’s Genomics team to support communications and submis-sion to FDA including:
• 5 day notices of change
• Submission of IDE supplements
• Tracking of minor changes to be reported at annual report.
• Coordinate annual report to FDA
• Manage all communications between program and FDA
• Maintain documentation in support of all submissions, approvals, implementations, and changes made to the IDE.
• Serve as AoURP’s SME on device management and submissions for FDA.
• Attend regular Regulatory Affairst Working Group Meetings with the Genome Center Awardees.
• Participate in the AoURP’s IDE Change Management Committee
• Serve as an SME on the AoURP Core Protocol
• Coordinate with AoURP awardees and program stakeholders to prepare submissions for the AoU IRB, including:
• Initial submissions of new research
• Amendments to existing/approved research
• Annual renewal of approved research
• Responses to IRB requests
• Provide guidance to stakeholders on submission and review process.
• Complete pre-review of submissions reviewing for:
• Consistency with past or other approved submissions
• Compliance with AoURP Policies
• Compliance with IRB requests
• Compliance with applicable Federal regulations (45 CFR 46, aka the Common Rule, and FDA regulations as applicable)
• Ensure adequate program level review of submissions prior to IRB review
• Maintain documentation of iterations of edits including final Program- and IRB-approved documents.
• Assist in management of communication of IRB determinations related to submissions.
• Ensure appropriate routing of IRB-approved materials to support timely implementation of the research.
• Coordinate with IRB management contractor and other support staff to ensure smooth operations of research development from concept to implementation.
The contractor must have:
• Master’s degree in a related discipline; three (3) years of specialized experience plus a Bachelor’s degree is equivalent to a Master’s degree.
• Minimum of four (4) years of experience.
• Experience in project management, written communications, qualitative analysis; prior ex-perience in IDE regulation and management (ideally working with the IDE-holder), in-cluding communications with FDA and investigators, research management (CRA/CRC) background also desirable.
• Expertise in Microsoft Office Suite (MS Word, Excel, Outlook, PowerPoint) and data-bases and data management tools.
• Strong communication skills, both oral and written.
• Excellent analytical, organizational and time management skills.
• Ability to multi-task and pay close attention to detail.
Number of positions