Sr. Clinical Trial Assistant

Location
Emeryville, CA
Posted
May 01, 2021
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
4D Molecular Therapeutics, Inc. (“4DMT”) is a clinical-stage gene therapy company pioneering the development of product candidates using targeted and evolved AAV vectors. 4DMT seeks to unlock the full potential of gene therapy using its platform, Therapeutic Vector Evolution, which combines the power of directed evolution with approximately one billion synthetic capsid sequences to invent evolved vectors for use in targeted gene therapy products. The company is initially focused in three therapeutic areas: ophthalmology, cardiology, and pulmonology. The 4DMT targeted and evolved vectors are invented with the goal of being delivered through clinically routine, well-tolerated and minimally invasive routes of administration, transducing diseased cells in target tissues efficiently, having reduced immunogenicity and, where relevant, having resistance to pre-existing antibodies. 4DMT is currently conducting three clinical trials: 4D-125 is in a Phase 1/2 clinical trial for XLRP, 4D-110 is in a Phase 1 clinical trial for choroideremia and 4D-310 is in a Phase 1/2 clinical trial for Fabry disease.

4DMT is focused on attracting and retaining the best people in the industry who identify with our mission and innovative results-driven approach. We offer an inspiring and collaborative environment that encourages individual contributions, recognizes performance in multiple ways, offers competitive salary and benefits, and provides challenging opportunities for career development.  4D Molecular Therapeutics is located in Emeryville, CA.

GENERAL SUMMARY:
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.
Responsibilities
  • 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
  • BA/BS required
  • Experience:
  • At least 4+ years of work experience supporting clinical trials
  • Skills:
  • 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)
  • Physical Requirements:
  • Adhere to 4DMT COVID protocols and policy  
  • Work remotely until safe to return to office

4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran and any other category protected under applicable federal, state, provincial and local laws.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities