Clinical Research Associate / Sr. CRA

Department: Clinical Operations

Location: South San Francisco, California, United States


As an in-house Clinical Research Associate / Sr. CRA in Clinical Operations, you will be responsible for supporting the Clinical Trial Lead to ensure the execution of assigned trials according to the study timelines and in compliance with ICH GCP, country regulations, and SOPs. This role will provide you with the opportunity to expand 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 Clinical Trial Lead
  • Assists the Clinical Trial Lead with study start-up activities including vendor RFPs, vendor selection and investigator selection
  • Assists in the review of study documents including, but not limited to, protocols and amendments, case report forms, site procedure manuals, study plans, ICF and tracking tools
  • Manage and organize internal team meetings, investigator meetings, and other trial-specific meetings, as requested. May present at Investigator Meetings.
  • Prepares and presents study progress reports
  • Maintains oversight of CRO clinical monitoring activities and the overall site management ensuring compliance with project-specific plans, Good Clinical Practices (GCP) and applicable regulations and tracking of site performance metrics
  • May conduct site pre-study, initiation, monitoring, close-out visits independently or with CRO or other team members and may be assigned as a monitor for a local site
  • Assist with the review of monitoring visit reports, tracking of review and issue resolution
  • Timely issue escalation to Clinical Study Lead and to assist with the resolution of issues
  • Responsible for sample tracking and reconciliation
  • Performs ongoing in-house review of CRF data in clinical database for completeness and accuracy and raises findings to the Clinical Study Lead and Lead Data Manager
  • Ensure the ongoing filing of study documents for assigned tasks in an electronic file system and transmission of study documents to the TMF
  • Perform QC of assigned sections of the TMF
  • Responsible for tracking IND Safety Reports and DSUR
  • Assists Clinical Study Lead with investigator contract, budget, and payment process including legal language and document structure as it impacts assigned studies
  • Assist with overseeing site payments by the CRO
  • Cultivate and maintain excellent working relationships with study vendors
  • Provide accurate and up-to-date information and study status reports to the clinical team members
  • Assist with aspects of vendor management under the guidance of the Clinical Study Lead
  • Must demonstrate good judgment in selecting methods and techniques for obtaining solutions
  • Follows study timeline to meet deadlines for assigned tasks and communicates with Clinical Study Lead with any updates or changes to the study timeline
  • Train and mentor Clinical Trial Associates
  • Partners with team members and other functional areas within Assembly including Regulatory, QA, Legal, Data Management and Biometrics
  • Contribute to the development of the Clinical Operations SOPs, best practices, work instructions, tools and templates
  • Approximately up to 20% domestic and international travel may be required for this position

Preferred Qualifications include

  • Bachelor’s degree with 5+ years, or master’s degree with 3+ years of relevant clinical operations experience
  • Knowledge of clinical trial processes, medical terminology and ICH GCP guidelines
  • Experience with Trial Master File management according to the DIA reference model
  • Experience using eTMF, EDC, IRT, CTMS, and other vendors systems/portals
  • Clear and concise verbal and written communication skill, including English fluency, s and strong organizational skills
  • Ability to multi-task, prioritize, track projects, and follow-through on-time with assigned tasks
  • Exceptional attention to detail
  • Ability to work independently and as part of a team
  • Proactive; applies critical thinking to improve execution of study tasks
  • Ability to learn quickly and effectively using newly acquired skills
  • Willing to embrace change and work in a changing environment
  • Able to work collaboratively across cultures and geographies
  • Proficiency in Microsoft Outlook, Word, PowerPoint, Excel
  • Fluency in Mandarin or other languages in both written and oral communication skills is desired, but not required
  • Experience working on global trials in China, India or other countries with high prevalence of HBV
  • Knowledge of hepatitis B virus and infectious disease

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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