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Research Assistant II, ACTG Project

Company: DLH Holdings Corp.
Location: Silver Spring
Posted on: June 6, 2021

Job Description:

Overview

Social & Scientific Systems (S3), a division of DLH, serves federal government clients throughout the United States and abroad delivering technology enabled solutions in key health and human services programs. The Company's core competencies include secure data analytics and statistics, clinical trials and laboratory services, a full suite of public health research offerings, performance evaluation, system modernization, operational logistics and readiness, and strategic digital communications. DLH has over 2,000 employees serving numerous government agencies. DLH's portfolio consists of Defense & Veteran Health Solutions, Human Services Solutions and Public Health & Life Sciences.

The AIDS Clinical Trials Group (ACTG) Network Coordinating Center (NCC) has supported public health research at SSS for over 30 years. This large research network is sponsored by NIH-NIAID-DAIDS to implement clinical trial research in infectious disease both domestically and internationally. The NCC staff provide administrative, scientific and executive committee support, and technical and scientific study support. The Research Assistant II position has the opportunity to assist and work closely with other scientific and technical staff.

The Research Assistant II is responsible for the day-to-day office functioning by handling a variety of general administrative duties including supporting the network quality management programs such as SOP management and training, SOP Training system and database support, word processing assistance and other document support, for project/s assigned.

Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

  • Assist in managing the project Quality Coordination Group (QCO) and network SOP management and training.
  • Provide SOP Administrative review of all Network SOPs and help in managing the network SOP Training system.
  • Assist the project SOP Administrator in managing and updating the SOP Review Matrix document and its associated documents including, SOP Admin Review Checklist and network SOP Process Checklist.
  • Develop checklists and other helpful tools for the project Good Documentation Practices (GDP).
  • Review and update of Project Management Plan (PMP) under the direction of the QCG Manager and Project Director.
  • Organizes, edits, produces and disseminates documents and materials drawn from single or multiple sources, monitoring standards for quality and project timelines.
  • Develops and maintains study related documents, organizational files, trial master files (electronic or paper), study records, and data systems. Functions as Super User for any eTMF and/or other software utilized by SSS and/or project assigned.
  • Assists with collection of essential study documents for projects, coordinates translation of essential study documents as necessary and assists project managers with IRB submissions for assigned studies.
  • Prepares memoranda, tracking reports, project status reports and communications for the supported staff. Assists in preparing proposals, and findings associated with assigned projects.
  • Assists with resolution of internal systems audits of assigned projects.
  • Establishes and maintains filing system for project documents, records and general correspondence. Uploads documents to portal system if required.
  • Assists in planning and organizing project team meetings and team functions. Develops, reviews and finalizes meeting minutes for sponsor/S-3 project team meetings and internal project team meetings. Follow up on action items as needed.
  • Maintains Management Information System (MIS) for projects as directed, entering and quality checking data as well as pulling reports as needed.
  • Assists with research and develop technical scientific materials as needed.
  • Performs additional duties as required.

Qualifications

Candidates for this position should have the following education/experience and demonstrate mastery of the following knowledge, skills, and abilities:

Education and Experience

  • Bachelor's degree and two years of related experience or high school completion and four years of related experience
  • Experience in clinical trials or scientific research preferred.

Knowledge, Skills, and Abilities

  • Must have excellent verbal and written communication skills.
  • Proficient in MS Word, MS Excel and MS PowerPoint.
  • Experience in website/portal system and/or Clinical Trials Management System considered a plus.

DLH is committed to fostering a diverse workforce and is proud to be an Affirmative Action/Equal Opportunity Employer of Minorities/Women/Protected Veterans/Individuals with Disabilities. All qualified applicants will receive consideration for employment without regard to race, creed, color, religion, sex, age, national origin, veteran status, disability, or any other classification protected by law.

Keywords: DLH Holdings Corp., Silver Spring , Research Assistant II, ACTG Project, Other , Silver Spring, Maryland

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