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Clinical Research Support Specialist

2 months ago

Washington, Washington, D.C., United States The George Washington University Full time
Position Overview:
The Biostatistics Center, an esteemed research entity affiliated with The George Washington University, is located in Rockville, Maryland.

This center plays a pivotal role in coordinating extensive multi-center clinical trials and epidemiological investigations, primarily funded by federal organizations such as the National Institutes of Health.

Renowned for its expertise in statistical management, the Biostatistics Center leads significant medical research initiatives that have both national and international implications.


Opportunity:

The Biostatistics Center is in search of a dedicated full-time Research Assistant to contribute to the NIH-funded project focused on identifying risk factors for Type 2 Diabetes in youth.

The selected candidate will be tasked with providing essential research support, maintaining comprehensive study documentation, conducting data quality assessments, and facilitating training sessions for research personnel.

Additionally, the Research Assistant will manage daily communications with clinical sites and reading centers, ensuring strict adherence to established study protocols.

This role involves collaboration with subcommittees and working groups, as well as interaction with programmers to generate research reports. Travel for site monitoring will be minimal, occurring only as necessary (less than 5%).


Key Responsibilities:
  • Conducting data verification and quality assurance, including editing and auditing through the data management system.
  • Designing and implementing training programs for research staff.
  • Assisting in the development and management of the study website, including technical support.
  • Maintaining accurate study documentation, including data collection forms and procedural manuals.
  • Acting as a liaison for study subcommittees and working groups, which includes preparing agendas, recording minutes, and facilitating discussions, as well as coordinating between the central office and clinical sites.
  • Supporting the acquisition and distribution of research materials, including vendor interactions as required.
  • Possessing a thorough understanding of the research protocol, procedural manuals, data forms, and other study documents to ensure compliance with study objectives.
  • Monitoring regulatory submissions and approvals related to the research study.
  • Collaborating with programmers and developers to maintain and test enhancements to the web-based data management system and study websites.
  • Engaging in center-wide committees focused on data management systems and website development.
  • Performing additional duties as assigned, which may include tasks logically related to the position.

Qualifications:
Candidates must possess a BA/BS in a relevant field, with the degree conferred by the start date of employment.
Preferred Skills:
  • Exceptional organizational abilities
  • Strong verbal and written communication skills
  • Meticulous attention to detail
  • Prior research experience is advantageous