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Job Category:Clinical Development

Who We Are

Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
 
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!


Job Summary:

  • Provide support to the Clinical Operations functional line in project-specific tasks, tracking and the overall management of clinical trials.
  • Assist with the preparation of documentation, receipt, collection, and initial/ongoing review of site regulatory documentation. Confirm completeness of documents, track dates, and distribute to appropriate team members for review.
  • Create and maintain study central files for the duration of the study including assisting in the file review and reconciliation for audits, and preparing study files for archival.
  • Maintain and update project tracking tools and databases, which may involve contacting others to gather information;
    track and assist with study start-up activities including site identification, selection and recruitment, regulatory document collection and review. 
  • Assist in the planning, organizing and executing of project-specific meetings, CRA training meetings, and Investigator meetings.
  • Actively participate and assist with the preparation and distribution of meeting agendas and minutes.
  • Create and maintain project-specific binders and related files as needed to house study records during the trial. 
  • Provide support in the development and distribution of study newsletters.
  • Support the team by providing information and supplies, as requested.
  • Maintain project-related status reports and support Clinical Operations staff with maintenance of project timelines.
  • Engage and correspond with vendors and contractors to ensure timely receipt of study documents and materials.
  • Process and track invoices and expense reports from vendors and contract personnel.
  • Ensure finalized clinical trial agreements/contracts are properly tracked, maintained, filed and forwarded to the sponsor/clinical site.
  • Prepare correspondence, spreadsheets and presentations utilizing Microsoft Office.

Qualifications/Requirements

  • Bachelor's degree and 1-2 years industry experience
  • Proficiency in Microsoft Word, Excel, and PowerPoint is required.
  • Experience with Microsoft Project and Access is a plus.
  • Excellent interpersonal, verbal and written communication skills.
  • A flexible attitude with respect to work assignments and new learning.  
  • The ability to read and interpret documents such as safety rules, SOPs and work instructions, procedure manuals, write routine reports and correspondence, and must be able to speak effectively in meetings.
  • Knowledge of ICH-GCP and the clinical trial process.  
  • Experience in review of site regulatory documents.
  • Must possess a customer service demeanor; must demonstrate a strong sense of urgency, teamwork, keen attention to detail, the ability to plan, organize and to prioritize multi-task workload. 

    Benefits:

DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.


Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.

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