Research Assistant II, ACTG Project
Company: DLH Holdings Corp.
Location: Silver Spring
Posted on: June 6, 2021
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.
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
- 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
- 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
- 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.
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
Knowledge, Skills, and Abilities
- Must have excellent verbal and written communication
- 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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