IRB Analyst

Cameo Consulting Group, LLC, a management consulting practice based out of Alexandria, VA, 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:

Protocol Review and Processing

• 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. T
• 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 to include regulatory, privacy, and VA Central IRB voting primary, secondary, and informed consent reviewers, ensuring that all reviews are completed in a timely manner, summarizing comments, and contacting the study team to request additional information and/or changes to the project or forms.
• 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, notifying all relevant parties, including but not limited to the national study team, all local participating sites, local participating research offices, and coordinating centers, of the results of each review and the regulatory basis for requested changes, until the study team has satisfied all identified reviewer and regulatory concerns and a final approval letter from the IRB is issued.
• Ensure all databases and tracking logs are kept up to date
• Manage communication with, and provides advice and guidance to Principal Investigators, Study Chairs, and Study Teams, throughout all stages of the study, from application submission to conclusion of the study.
• Manage all post-approval monitoring activities as assigned by IRB Management staff to include the processing of modifications to approved studies, continuing review or annual reports as required, and the processing of reportable event reports to include unanticipated problems, protocol deviation and violations, local RCO and other audit reports, and complaints.
• 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

OTHER DESIRED QUALIFICATIONS:

• 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

HOURS OF OPERATION:

General business hours, typically 8-430 (with flexibility, M-F.)

ABOUT CAMEO:

Cameo provides a competitive benefit package to its employees that is replete with training programs and continuous education features that few others even attempt to duplicate. Our packages are offered to all full-time exempt employees on day one* and they offer many standard features one would expect to find from an industry leader, the details of which are outlined in our handbook. Below is a highlight of our benefit offerings:

• 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

Cameo Consulting Group, LLC is an EEO Employer - M/F/Disability/Protected Veteran Status