Job description

Position Objective: 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. Duties and 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 DataFaxsystem or other EDC systems - Participate in the generation study QAQC plan using DataFaxs 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 fieldteams 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 intimely and accurate logging of samples to the system • Assist in programming VBA script and macros to assist LMVR researchers withautomation 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 needsinventory 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. Basic Qualifications: • 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. Preferred Qualifications: • 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 *This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required by this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. GAP Solutions provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job, email us at recruiting@gapsi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law. This position is contingent upon contract award.

Requirements

Must-haves

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 DataFaxsystem or other EDC systems - Participate in the generation study QAQC plan using DataFaxs level system
Coordinate data entry and QA/QC activities remotely
Provide BSI-II system training to researchers at LMVR - Update and develop SOPs for BSI-II to highlight the importance of user responsibility intimely and accurate logging of samples to the system
Assist in programming VBA script and macros to assist LMVR researchers withautomation 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 needsinventory 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
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.

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
Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status or other characteristics protected by law.
This position is contingent upon contract award.

Application prep

Use the role’s language and application details while tailoring your materials.

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