Sr. Clinical Trial Assistant

D Molecular Therapeutics (4DMT), located in Emeryville, CA, is a global leader in gene therapy product research and development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4DMT, our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus (AAV) variants platform to treat serious unmet medical conditions.

4DMT seeks a motivated and experienced Senior Clinical Trial Assistant to support the Company’s clinical trial activities.  This position reports to the CTM/Sr.CTM, Clinical Operations and will be responsible for supporting the day-to-day operations of multiple phase 1-2 clinical trials including trial start-up, conduct and close-out activities.  This role requires strong, professional written and verbal communication skills, good organization and attention to detail, and the ability to consistently provide high-quality work while managing competing priorities and maintaining tight timelines.  This person must be interested in working in a fast-paced, team-oriented environment and be willing to work beyond their job scope to achieve department and company objectives.

Specific Responsibilities include (but not limited to):

  • Coordinate tracking of a clinical trial(s) under the oversight of the Clinical Trial Manager (CTM)
  • Organize, maintain and participate in audits and close out of the Trial Master File (TMF/eTMF)
  • Collect, track and conduct initial review for completeness of site regulatory documents for IP release and/or TMF filing
  • Maintain multiple tracking spreadsheets following the progress of assigned clinical trials, such as study subject tracking, essential document tracking, and sample and investigational product tracking
  • Track and coordinate CRO and third-party vendor activities, including vendor-provided meeting minutes, study updates and trackers
  • Receive and review all regulatory documents from sites (direct or through CRO) for accuracy and compliance to applicable SOPs and regulatory guidelines
  • Ensure timely updates are provided to CTM for updating of ‘Clinicaltrial.gov’ (site updates/changes)
  • Track and route new CDAs, contracts and Work Orders through established legal approval process (CTAs, MSAs, work/task orders)
  • Perform first pass review of all site and vendor invoices including tracking and generation of monthly/quarterly accruals for finance
  • Assist with the development of site tools and clinical trial start-up activities
  • Assist and/or contribute to the creation and maintenance of study materials for clinical studies, including but not limited to site and CRA training material, regulatory document templates, study binders, study plans/manuals, study communications and presentations
  • Assist in tracking of trial IP and development of Pharmacy Manuals
  • Participate in the EDC and IXRS specification process, as appropriate
  • Communicate directly with sites, Contract Research Organizations (CROs) and field CRA/monitors to obtain updated information, essential documents, etc. to assist with driving start-up, study conduct, and/or close-out activities
  • Assist with tracking of clinical trial progress including status update reports, as requested
  • Assist with the organization, management, and conduct of internal team meetings, investigator meetings and other trial-specific meetings, including minute taking and action item log tracking
  • Assist in tracking of clinical lab samples and central reader/lab data, including tracking of sample shipments and reconciliation
  • Utilize EDC/CTMS systems to acquire and synthesize data, metrics, or reports as necessary (enrollment data, randomizations, data cleaning, SAEs, etc.) for CTM, specific meetings or management updates
  • May assist CTM in tracking and follow-up of monitoring visit reports and unresolved issues
  • Other duties as may be assigned

Requirements

  • High school diploma required; BA/BS, degree strongly preferred
  • At least 2 years of work experience supporting clinical trials
  • Basic knowledge of clinical trial operations, ICH GCP Guidelines and other applicable regulatory requirements
  • Proficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and Outlook
  • Ability to prioritize and manage competing priorities
  • Team oriented and ability to effectively collaborate with study team, cross-functional team members, and external partners
  • Willing to travel as trial needs demand (<5% anticipated)

Qualified candidates may submit a resume and cover letter to jobs@4dmt.com