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Full-timeDescriptionWelcome! At Digital Infuzion, we believe that everyone deserves to live a better, healthier life. That's why we're dedicated to providing life science researchers with faster insights and health providers with on-demand data and tailored software solutions. Our passion for developing innovative healthcare solutions goes beyond ordinary health IT services to include comprehensive translational research support. If you're looking for a creative, open, and growth-oriented environment where you can do what you love while helping people live healthier lives, then keep scrolling - we may have just the opportunity for you.
Career Opportunity
Are you ready to integrate your clinical research passion with groundbreaking technology? Join us at Digital Infuzion as a DSMB Executive Secretary and contribute directly to the nexus of healthcare and advanced informatics. Your expertise will be pivotal in steering the future of clinical research within a forward-thinking organization that acknowledges and values your dedication and skills.
Position Overview
We seek a detail-oriented DSMB Executive Secretary with clinical research coordination experience. In this role, you will collaborate closely with the Project Director and maintain active communication with Safety Committees and clinical trial personnel. Your responsibilities will include coordinating the Safety Committees and liaising with the clinical research teams. This role is ideal for those passionate about applying their clinical research acumen in a dynamic, innovative environment.
Key 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.
Requirements
- Educational Background: 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.
- 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.
- Specialized Knowledge:
- Familiarity with Data Safety Monitoring Board (DSMB) processes and procedures.
- Knowledge of FDA guidance concerning Data Monitoring Committees.
- Skills:
- 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.
These qualifications ensure the candidate can effectively contribute to and thrive in our innovative, collaborative, and technology-driven healthcare setting.
Digital Infuzion, Inc. is an Equal Opportunity Employer. EOE/AA/M/F/D/V
It is the policy of Digital Infuzion, Inc. to provide equal employment opportunities without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, marital status, veteran status, genetic information, or any other protected characteristic under applicable law.
