A080 IRB Technical Writer

Cameo Consulting Group, LLC, a management consulting practice based out of Alexandria, VA, is seeking a qualified and available Technical Writer to support a potential Federal client specializing in Veteran healthcare research initiatives in Washington, DC. The positions is full-time, long-term in nature, and available upon contract award.

SCOPE

The Technical Writer/Editor is responsible for preparing the Institutional Review Board (IRB) agenda and meeting minutes and ensuring that all prepared meeting minutes meet all regulatory and policy requirements as well as all requirements specified in VA CIRB SOPs. In addition to the preparation of VA CIRB meeting agenda and meeting minutes, the Technical Writer shall assist the VA CIRB Panel and Network Administrators in the preparation, review and editing of letters, forms, and VA CIRB SOPs. This includes development of document and email templates with periodic review for consistency, accuracy, and as needed personalization based on review/specific situation.

GENERAL DUTIES

• 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.
• Provide support to during meetings by attending meetings, tracking attendance throughout the duration of the meeting, and taking detailed notes during the meeting.
• Prepare meeting minutes.

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.
• Experience using MS Access
• Ability to pass background check. Prior Government Clearance preferred.
• Bachelor’s Degree in English, Journalism, or related discipline

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

PLACE OF PERFORMANCE:

A mix of onsite at VA facilities in Washington, DC, telework, and occasional support at corporate office in Alexandria, VA.

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
• Tuition Reimbursement
• 3 Weeks Paid Time Off
• 10 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
• Employee Referral Bonus for Tough-to-Fill posts
• Free annual membership to professional organization of choice (i.e. NCMA, PMI)