Senior Clinical Research Associate
Employment Type: Full-Time
As an in-house Senior 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
* 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
* 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
* Some domestic and international travel may be required for this position.
Preferred Qualifications include:
* Bachelor's degree with 8+ years, or master's degree with 6+ years of relevant clinical operations experience. Exceptions will be made for candidates who have direct experience in vendor management, site monitoring, and relevant therapeutic experience such as NASH or viral hepatitis.
* 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, 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
* Experience working on global trials in APAC with high prevalence of HBV
* Knowledge of hepatitis B virus and infectious disease
* There is flexibility to work from home some days; however, this is not a remote position and is based onsite at our South San Francisco, CA location. Relocation assistance is not available.
About Assembly Bio
Assembly Biosciences (NASDAQ: ASMB) is an ambitious clinical stage biopharmaceutical company with cutting-edge therapeutics potentially capable of improving the lives of millions living with chronic hepatitis B virus (HBV) infection around the world. We are currently focused on 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.
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 set our sights high-and pursue our goals with determination. Our unique organization stands ready to welcome talented, motivated individuals, who share our ambitions.
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.