Protocol Manager
Apply NowCompany: N4 Solutions, LLC
Location: Bethesda, MD 20817
Description:
N4 Solutions is looking for you! Come join our team and be a part of our mission! Our mission is to evaluate, collaborate, and innovate with customers and partners to create business, scientific, and technology solutions that overcome complex challenges while motivating a highly competent workforce to deliver on the promise of excellence! N4 Solutions' greatest assets are our employees! Join our dynamic team and be a part the solution!
N4 Solutions, LLC is seeking a Certified IRB Professional (IRB) Protocol Manager at The National Institute of Health in the Office of Directors. This position is contingent upon passing a government suitability test.
Roles & Responsibilities:
The N4 Solutions Equal Employment Opportunity (EEO) Policy is to provide a fair and equal employment opportunity for all employees and job applicants regardless of race, color, religion, national origin, gender, sexual orientation, age, marital status or disability. N4 Solutions hires and promotes individuals solely on the basis of their qualifications and achievements for the job to be filled .
N4 Solutions, LLC is seeking a Certified IRB Professional (IRB) Protocol Manager at The National Institute of Health in the Office of Directors. This position is contingent upon passing a government suitability test.
Roles & Responsibilities:
- Give regular progress reports to sponsor and stakeholders.
- Provide project management support for large and/or complex projects with internal and external stakeholders and other project participants
- Organize the exempt and not human subjects research (NHSR) determination process, from receipt of submission to final determination, annual status update tracking, and maintenance of all programs exempt and NHSR determination records as delegated by the All of Us IRB
- IRB review; brainstorm with program staff and IRB staff/leadership on feasibility of program priorities, when necessary
- Work with staff on existing projects and/or the development, initiation and execution of new project initiatives
- Prepare scientific and programmatic presentation materials such as tables, graphs, slides, abstracts, posters and overheads by assimilating and mastering the scientific data and programmatic con-text for use at presentations and meetings
- Maintain ongoing, proactive communication with key personnel throughout the initiative; gather, provide and exchange information with Network investigators, their staff and other relevant individuals
- Serve as lead point of contact for RCB on the program's ancillary studies efforts; partner with ancillary study teams on study development, negotiate IRB review and responsibilities, coordinate submission and IRB reviews, contribute to and assist in maintaining program's Ancillary Studies Handbook
- Master's degree in History or related field,
- Experience in Institutional Review Board (IRB) amendments and continuing reviews and submissions, Non-Disclosure Agreement (NDA), HIPAA, and Human research subject protections.
- Strong organizational skills and the ability to work independently or under minimal guidance.
- U.S. Citizenship required.
The N4 Solutions Equal Employment Opportunity (EEO) Policy is to provide a fair and equal employment opportunity for all employees and job applicants regardless of race, color, religion, national origin, gender, sexual orientation, age, marital status or disability. N4 Solutions hires and promotes individuals solely on the basis of their qualifications and achievements for the job to be filled .