[Hiring] IRB Analyst @Cameo Consulting Group

Role Description

Cameo Consulting Group, LLC is seeking multiple qualified and available Protocol Coordinators to support a potential Federal client specializing in Veteran healthcare research initiatives in Washington, DC. The position is 100% remote.

General Duties:

• Support the VA CIRB by processing new study submissions and managing post-approval monitoring (amendments, continuing review, and reportable events) for all assigned human subjects research studies.
• Ensure all documents produced by and in support of the VA CIRB are written clearly, concisely, and incorporate all required regulatory and VA policy requirements.
• Use the approved IRBNet and VA CIRB platform for managing research studies.
• Manage PI applications and Local Site Applications from all local participating sites for the assigned study.
• Perform administrative and technical reviews of assigned study applications to identify missing or incomplete documentation and to highlight areas that may be deficient or require clarification.
• Complete required review checklists and communicate findings to the study team and/or assigned IRB members as necessary.
• Coordinate review of the study submission among the study team and assigned IRB members, ensuring that all reviews are completed in a timely manner.
• Maintain a complete file of all submitted study documents, results of all reviews by assigned reviewers, and all correspondence in accordance with VA CIRB SOPS and other regulatory requirements.
• Prepare interim and final letters to the study team for actions eligible for expedited review.
• Ensure all databases and tracking logs are kept up to date.
• Manage communication with, and provide advice and guidance to Principal Investigators, Study Chairs, and Study Teams throughout all stages of the study.
• Manage all post-approval monitoring activities as assigned by IRB Management staff.
• Assist with preparing for oversight inspections and site visits as necessary.

Qualifications

• 3 years experience in IRB performing reviews of non-exempt human subject research.
• Familiarity with the functions of the Institutional Review Board (IRB), the Common Rule, and FDA regulations.
• Ability to pass background check. Prior Government Clearance preferred.
• Bachelor’s Degree preferred.

Requirements

• Positive attitude.
• Critical thinking skills.
• Accountable for actions.
• Customer service mentality.
• Takes Responsibility for Work Products.
• Excellent communication and writing skills.
• Ability to separate the issue/problem from the person.
• Ability to work independently AND work as a team member.

Benefits

• 401K Plan.
• 3 Weeks Paid Time Off.
• 11 Paid Federal Holidays.
• Jury Duty and Bereavement Leave.
• Medical Insurance - Multiple Nation-Wide Coverage Options.
• Dental Insurance - 100% Employer covered for Employee.
• Vision Insurance - 100% Employer covered for Employee.
• Life Insurance Package - 100% covered by Employer.
• Short-Term and Long-Term Disability Insurance Options.
• Corporate Shopping Perks from TicketsatWork.com.