Senior Clinical Trial Associate
Department: Clinical OperationsLocation: South San Francisco, California, United States
Summary:
As a Senior Clinical Trial Associate (Sr. CTA) in Clinical Operations, you will be responsible for supporting the study team to ensure the execution of assigned trials according to the study timelines and in compliance with ICH GCP, country regulations, and SOPs. In collaboration with the Clinical Trial Manager (CTM)/Sr. CTM, one of your top priorities is to make sure the Trial Master File (TMF) is inspection ready throughout all phases of the trial. As an experienced CTA, you will assist with onboarding and mentoring of CTAs and will contribute to process improvement initiatives. 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 CTM/Sr. CTM
- Cultivate and maintain excellent working relationships with study vendors, including Contract Research Organizations (CROs)
- Assist in planning and organizing Investigator Meetings
- Schedule the Study Management Team (SMT) and other vendor meetings and draft the SMT meeting agenda and minutes and update the action item/decision/issue escalation log
- Provide accurate and up-to-date information and study status reports to the clinical team members
- Perform data extraction and uploads in various programs/systems
- Create and maintain trackers including subject screening and enrollment, training, study staff contact list, clinical trial materials
- Manage submissions and updates of trial information in clinical trial registries (e.g. CT.gov, EudraCT) in coordination with the CTM/Sr. CTM
- May assist with aspects of vendor management under the guidance of the CTM/Sr. CTM
- Organize and maintains shared spaces (SharePoint, MSTeams) for the study team
- Set up folders as need for assigned trials, file documents to shared spaces, review shared space to ensure others are updating files
- Serve as central contact of the study team in study-related communications, documentation, and correspondence
- Collect, review for accuracy, and file essential documents in the Trial Master File
- Review and track essential documents such as informed consent documents, IRB approvals, financial disclosure forms, and other study-related documents for the study team
- Maintain in-house electronic storage of clinical document archives and TMF
- Assist in study start up activities including, but not limited to, review of informed consent forms, study plans/manuals and other essentials documents
- Works with TMF document owners to ensure documents are filed and complete according to the TMF plan
- Lead the periodic QC of the TMF and ensure archival of TMF for completed trials
- Follows study timeline to meet deadlines for assigned tasks and communicates with CTM/Sr. CTM with any updates or changes to the study timeline
- Train and mentor Clinical Trial Associates
- Provide suggestions and solutions for areas of process improvements in Clinical Operations
- Contribute to the development of the Clinical Operations SOPs, best practices, work instructions, tools and templates
- Lead process improvement initiatives for the Clinical Operations group and create timelines to manage project
- Approximately up to 10% domestic and international travel may be required for this position
Preferred Qualifications:
- Bachelor’s or master’s degree with 2+ years of relevant experience
- Knowledge 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, 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
- 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 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
- 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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