Database Administrator (51847)

GAP SOLUTIONS INC•Rockville, MD

42d•$100,000 - $150,000•Onsite

About The Position

The Database Administrator will provide support to the NIAID’s Clinical Center within the National Institutes of Health. To provide comprehensive database administration and clinical research data management support that ensures the integrity, accuracy, security, and availability of clinical and biospecimen data for ongoing NIH clinical research protocols. The objective of this role is to maintain uninterrupted clinical research operations by supporting data quality review, regulatory reporting, biospecimen tracking, and compliance with IRB, biosafety, and federal regulatory requirements, thereby enabling timely research analysis, participant safety reporting, and successful execution of NIAID clinical research activities. This role provides essential database administration and clinical data management support for ongoing clinical research protocols conducted at the NIH Clinical Center in Bethesda. Responsibilities include management and maintenance of clinical research databases, biospecimen tracking systems, clinical data entry and validation, data quality assurance, and clinical data analysis. The position also supports preparation of data for IRB safety reporting and publication of clinical research findings. In addition, the role supports laboratory operational compliance through accurate handling, accessioning, storage, and tracking of human blood and tissue biospecimens while ensuring adherence to biosafety standards, regulatory requirements, and data management policies.

Requirements

Bachelor’s Degree in Computer Science Biology or a related discipline.
4 years of experience plus a High School Diploma is equivalent to a bachelor’s degree.
Minimum of two years of experience in database programming or a related field.

Nice To Haves

Ability to communicate effectively, orally and in writing, with non-technical and technical staff
Detail-oriented and possess strong organizational skills with the ability to prioritize multiple tasks and projects

Responsibilities

Designing and maintaining databases for data capture, retrieval, and analysis of clinical research data
Conducting QA/QC audits of clinical data for accuracy, timeliness, and completeness
Ensuring compliance with 21 CFR Part 11 requirements on data security, audit trails, and access control
Developing and updating Standard Operating Procedures (SOPs) to ensure regulatory adherence and accurate specimen tracking
Managing biospecimen processing and inventory tracking for human blood and tissue samples collected under approved protocols
Generating validated datasets and safety reports required for Institutional Review Board (IRB) submissions and publication of clinical findings
Participate in the development of Case Report Forms CRFs for use by the DataFax system or other EDC systems
Participate in the generation study QAQC plan using DataFax’s level system
Coordinate data entry and QA/QC activities remotely
Participate in regular QA/QC audits of database which include validating data entered into system; provide constructive feedback to field teams regarding data entry; review automatically and manually generated queries; generate regular QC reports for field teams containing errors and inconsistencies on CRFs for correction
Create custom and standard reports of data and export data into various analysis dataset formats such as Excel, Access
Ensure that system is being used correctly and in compliance with 21 CFR Part 11 (security, access control permissions, audit trails)
Provide BSI-II system training to researchers at LMVR
Update and develop SOPs for BSI-II to highlight the importance of user responsibility in timely and accurate logging of samples to the system
Assist in programming VBA script and macros to assist LMVR researchers with automation of commonly repeated procedures performed in Microsoft Office products
Ensure data management staff adherence to guidelines detailed in the SOPs
Design custom databases in Microsoft Access for research teams based on their needs (inventory tracking, scheduling tools, data summary logs)
Respond to all data requests and produce custom queries, ensure that research teams data needs are satisfied
Develop and review Study data management plans, QA/QC plans and SOPs that will deliver accurate, timely, consistent, and quality data
Resolve all data related issues raised with the datasets produced
Perform sample processing for human or animal biospecimens for LMVR researchers, to include processing and storage of human blood and other body fluids and tissues. (This does not include direct collection of specimens from the human or animal subjects.)
Work products and documents related to maintaining designing custom databases in Microsoft Access for research teams based on their needs.
Work products and documents related to developing and reviewing study data management plans, QA/QC plans and SOPs that will deliver accurate, timely, consistent, and quality data.
Work products and documents related to providing training to field teams on proper completion of CRF forms as related to DataFax requirements either remotely or in person.
Work products and documents related to ensuring that the Datafax system is being used correctly and in compliance with 21 CFR Part 11 (security, access control/permissions, audit trails).
Work products and documents related to ensuring data management staff adherence to guidelines detailed in the SOPs.
Work products and documents related to processing and storage of human and animal biospecimens.