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Digital Infuzion · 2 days ago
DSMB Regulatory Affairs Coordinator
Rockville, MD
Full-time
Onsite
Mid Level
3+ years exp
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Responsibilities
Communication and Coordination: Forge strong relationships with DSMB Specialists, Executive Secretaries, investigators, and program officers. Coordinate DSMB member onboarding and offboarding processes and ensure the smooth execution of clinical research projects across teams.
DSMB Support: Manage and facilitate DSMB meetings, prepare meeting materials, document proceedings, and uphold strict confidentiality in compliance with standard protocols.
Document Management: Proficient use of SharePoint and other systems to manage and oversee documents and data relevant to DSMB activities.
Project Administration: Handle administrative tasks for assigned trials, ensure documentation is processed and maintained accurately, and support project-level planning and execution.
Regulatory Compliance: Oversee adherence to regulatory standards and ethical guidelines for clinical trials and maintain up-to-date knowledge of regulatory documents and guidelines.
Clinical Trial Protocol Meta Data Management: Coordinate the collection, entry, and validation of data and files, liaise with data management teams to ensure accuracy, and resolve discrepancies.
Training: Develop and maintain training materials and documentation, ensuring all involved in clinical studies are well-informed and compliant with regulatory and internal standards.
Qualification
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Required
A bachelor’s degree in a relevant field such as Life Sciences, Nursing, Healthcare, Business Administration, Public Health Administration, or Biostatistics, or an equivalent combination of education and work experience.
At least three years of clinical research experience is essential, with a clinical research coordination background preferred. Candidates should thoroughly understand clinical research regulations, guidelines, and best practices.
Familiarity with Data Safety Monitoring Board (DSMB) processes and procedures.
Knowledge of FDA guidance concerning Data Monitoring Committees.
Excellent organizational, communication, and problem-solving abilities.
Proficiency in Microsoft Office applications (Outlook, Word, PowerPoint, SharePoint).
Competence in using software tools and platforms necessary for virtual meetings and remote collaboration (Zoom, MS Teams).
Ability to efficiently work independently and as part of a team in a matrixed environment.
Ability to quickly learn and effectively navigate clinical trial management and electronic data capture systems.
Preferred
Clinical research coordination background.
Company
Digital Infuzion
Digital Infuzion is a computer software company offering clinical informatics services.
51-200 employees
H1B Sponsorship
Digital Infuzion has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (4)
2021 (8)
2020 (4)
Funding
Current Stage
Growth StageLeadership Team
Hemant Virkar
President
Recent News
Company data provided by crunchbase
