Archivist/Records Manager - Goldbelt, Inc.

Goldbelt Frontier is committed to providing support for a range of health technology management operations, projects, and services across the government and commercial industries. Frontier collaborates with clients and partners with other businesses to ensure that the right solution with the right people is delivered to meet the client’s needs. Many senior project managers and business analysts are subject matter experts in their respective fields. Frontier understands how to support multiple stakeholders to aid in developing and implementing national policies, strategies, and doctrine.

Summary:

Goldbelt Frontier, LLC is looking for a Records Manager who will also serve as a Good Laboratory Practice (GLP) Archivist. The primary responsibility will be archiving and retrieving of all data (including e- data) generated from the conduct of non-clinical studies in accordance with the Food and Drug Administration Good Laboratory Practice (GLP) and other applicable regulations. To allow for study reconstruction, the Contractor will be responsible for the storage and retrieval of all study data in accordance with GLP and governing Standard Operating Procedures (SOP). GLP Archivist/Records Manager shall provide support specific to the Records Digitization Project under the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) Transition Office, and secondarily support office level users of the Army Records and Information Management System (ARIMS) for record maintenance.

Essential Job Functions:

• Establish effective communications with Study Directors Quality Assurance, and other key study personnel
• Ensure that all electronic and paper raw data, documentation, protocols (including amendments/deviations), final reports and samples collected from the study are retained in accordance with the approved protocol and GLP regulations
• Ensure that the archive system allows for orderly storage and expedient retrieval of all raw data, documentation, protocols, samples and final reports, for example, during an FDA inspection
• Ensure that storage conditions are maintained to prevent deterioration of documents or samples for the duration of their retention. At the request of the Sponsor, the GLP Archivist/Records Manager will coordinate the transfer of study data/samples to off-site archival locations, if required
• Ensure that only authorized personnel have access to the archive in accordance with governing SOP GLP regulations
• Ensure that materials retained in the archive are appropriately indexed to permit expedient retrieval
• Ensure that records, raw data and samples are retained in accordance with the protocol and/or applicable FDA GLP regulations
• Accompany QARCO, Sponsor, and regulatory auditors, safety inspectors, and maintenance personnel during inspections. 
• Update and generate new SOP’s
• Complete GLP training and other mandatory training requirements and adhere to Institute safety requirements
• Serve as point person at USAMRIID for the digitization project which supports the Transition Office (TO) and the move to the new USAMRIID facility, review Serialization
• Forms completed by the divisions/offices; draft summary SF135s for long term/permanent files for submission/approval of Federal Records Center (FRC); assist divisions/offices with arranging boxes for transfer to FRC
• Ensure compliance and relevance of ARIMS within each USAMRIID office; assist all offices with inventory of records and updating Office Records Lists (ORLs) annually; complete annual USAMRDC tasker; update office symbols in ARIMS as required; assist offices with retrieving and returning hard copy records from FRC or other Records Holding Area
• Meet weekly/biweekly with Records Digitization Subcommittee. Meet monthly for Digitization Working Group. Meet as needed with USAMRIID offices for digitization assistance, training, records maintenance, and annual ORL updates
• Draft and revise digitization Standard Operating Procedures (SOPs) in coordination with Records Digitization Subcommittee
• Develop and present training for Digitization Project (division level), and for ARIMS use/maintenance (general user level)
• In coordination with Digital Archivist (Transition Office), arrange for large scale destruction of eligible short-term files; arrange for pick up/shipment of eligible hardcopy records to FRC; draft and submit approval for new disposition instructions to RMDA
• Coordinate with USAMRIID Transition Office, USAMRDC/MEDCOM Records Managers, Army Records Manager, Army Records Management and Declassification Agency (RMDA), and NARA as needed
• Improve quality of Record Management (RM) at USAMRIID. Possible tasks include draft other internal regulations, SOPs, training guides, or forms as needed to improve Records Management in the institute; formalize system to communicate records freezes; coordinate with USAMRIID Information Services Office (ISO) and Business Plans and Programs (BPPO) to ensure RM requirements are included in information systems; address management of secure files; research legality and authenticity of electronic formats for various record types
• Prepare, edit, review, and maintain non-military and military correspondence in accordance with Army and local regulations (AR 25-50, DA Memo 25-52 and other references/guidance provided)

Necessary Skills and Knowledge:

• Familiarity with Records Management Systems and Directives
• Demonstrate strong analytical skills, reading comprehension, and attention to detail
• Possess strong leadership and communication skills (both oral and written)
• Must be a self-starter, have strong organization skills
• Able to work independently without direct supervision and be able to accept guidance and direction
• Excellent skills with Microsoft Office suite to include Word, PowerPoint and Excel

Minimum Qualifications:

• Bachelor’s Degree in related field, or equivalent work experience
• Minimum 3-5 years of related specialized experience
• experience in a field relevant to program management, schedule management (development and analysis) and/or analytical functional areas
• Experience supporting contract management procedures and contract deliverables, planning and program development, analysis of records, docket, and information management problems, and design of strategies and procedures to meet ongoing records management needs
• Must be CAC eligible/approved

 Preferred Qualifications:

• Master’s Degree in a related field
• Certified Records Manager (CRM), Certified Records Analyst (CRA), or Information Governance Professional (IGP) is desired but not required

The salary range for this position is $70,000.00 - $77,000.00 Annually.

Pay and Benefits
At Goldbelt, we value and reward our team's dedication and hard work. We provide a competitive base salary commensurate with your qualifications and experience. As an employee, you'll enjoy a comprehensive benefits package, including medical, dental, and vision insurance, a 401(k) plan with company matching, tax-deferred savings options, supplementary benefits, paid time off, and professional development opportunities.