Clinical Trial Associate

Department: Clinical Operations

Location: South San Francisco, California, United States


As a Clinical Trial Associate (CTA) in Clinical Operations, you will be responsible for supporting the study team to ensure the execution of assigned trials according to timelines and in compliance with ICH GCP, country regulations, and SOPs. In collaboration with the Clinical Trial Manager (CTM)/Sr. CTM, one of your key deliverables is to make sure the Trial Master File (TMF) is inspection ready throughout all phases of the trial. This role will provide you with the opportunity to build and broaden your knowledge and experience in clinical research and management of clinical trials.

Key Responsibilities include:

  • Support the planning, conduct, management and completion of assigned clinical trials under the leadership and guidance of the CTM/Sr. CTM
  • Schedule the Study Management Team (SMT) and other vendor meetings and take meeting minutes
  • Assist in planning, organization and implementation of Investigator Meetings
  • Create and maintain study trackers including subject screening and enrollment, training, study staff/vendor contact list
  • Assist in the distribution and tracking of clinical trial materials such as study-related documents and equipment
  • Assist in timely updates of study information on clinical registry sites (e.g., EudraCT)
  • Perform data extraction and uploads in various study related programs and systems
  • Organize and maintain collaborative software spaces (SharePoint, MSTeams) for the study team
  • Set up folders as needed for assigned trials, file documents to shared spaces, review shared space to ensure others are updating files
  • Collect, review for accuracy, and file essential documents in the TMF
  • Review and track essential documents such as informed consent documents, IRB approvals, financial disclosure forms, and other study-related documents for the study team
  • Assist in study start up activities including, but not limited to, review of study plans/manuals and other essential documents
  • Work with TMF document owners to ensure essential documents are filed and complete according to the TMF plan
  • Lead the periodic QC review of the TMF and ensure archival of the TMF for completed trials
  • Follows study timeline to meet deadlines for assigned tasks and communicate with CTM/Sr. CTM with any updates or changes to the study timeline
  • Provide suggestions for process improvements in Clinical Operations and may implement solutions for process improvement
  • Contribute to the development of SOPs, work instructions, tools and templates
  • Perform other duties in support of Clinical Operations, as requested
  • Approximately up to 10% domestic and international travel may be required for this position

Preferred Qualifications:

  • Bachelor’s degree with clinical, laboratory or other relevant experience
  • Understanding of clinical trial processes and ICH GCP guidelines
  • Experience filing essential documents according to the DIA reference model
  • Familiar with using eTMF, EDC, IRT, CTMS, SharePoint and other vendors systems/portals
  • Clear and concise verbal and written communication skills and strong organizational skills
  • Ability to multi-task, prioritize, track projects, and follow-through on-time with assigned tasks
  • Exceptional attention to detail
  • Demonstrated effectiveness working with multiple functions in a professional manner
  • Proactive; applies critical thinking to improve execution of study tasks
  • Ability to learn quickly and effectively using newly acquired skills
  • Willing to go beyond the scope of the job to help the department and organization achieve their objectives
  • Willing to embrace change and work in a changing environment
  • Able to work collaboratively across cultures and geographies
  • Fluency in English in both written and oral communication skills
  • Proficiency in Microsoft Outlook, Word, PowerPoint, Excel, other software and systems
  • Fluency in Mandarin or other languages in both written and oral communication skills is desirable, but not required

About Assembly Bio

Assembly Biosciences (NASDAQ: ASMB) is a clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving millions of lives around the world.  We pride ourselves on creating a culture and work environment that is scientifically driven, ambitious, and collaborative. We encourage diversity of thought that leads to great innovation and are looking to add great people to our dynamic team who are driven to transform the lives of patients.  We are currently focused on the development of two intelligently designed, scientifically novel clinical platforms:

An HBV program intent on creating a new class of oral therapeutics to finally cure hepatitis B.  Our program is built on ingenuity, vision and experience and has the potential to improve cure rates for individuals with chronic hepatitis B (HBV) in our lifetime. Our strong scientific expertise in discovering small molecules targeting the HBV core protein has made us a leader in the field.

A Microbiome program of potentially life-changing oral live biotherapeutics to transform the treatment of an entire range of diseases linked to the microbiome.  We believe our Microbiome platform represents a best in class approach, translating naturally evolved, bacteria-host pharmacological interactions into rationally selected, live oral biotherapeutics.

Assembly Bio has a strong balance sheet and is well-positioned to advance our innovative research and potential medicines in HBV-cure and the Microbiome.  Headquartered in South San Francisco, CA, Assembly Bio also operates a microbiome manufacturing facility in Groton, CT, and has offices in China.

AAP/EEO Statement

Assembly Biosciences is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. We are committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.

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