Position Title: Clinical Trials Assistant
Aligos Therapeutics, Inc. is a biotechnology company located in South San Francisco, California that is developing novel medicines to treat liver diseases in virology and oncology. Aligos is pursuing the development of both oligonucleotide-based and small molecule therapeutics, each addressing major commercial market opportunities.
At Aligos, our science is the key to our success, and to improving patients’ quality of life. Our pipeline of developing novel compounds and investigative therapies reflects our commitment to bring innovative products to patients with unmet needs in the area of liver diseases. This is an exciting opportunity to become an early employee of a high energy, pre-IPO Research and Development company. We are looking for an enthusiastic clinical research scientist who understands and appreciates the entrepreneurial environment of a “start-up” and who is willing to do what it takes to contribute to the success of the company.
The CTA will report directly to the Head of Clinical Operations and will be responsible for assisting one or more Clinical Study Managers in the operational implementation of one or more clinical trials. This individual will be a key member of a small clinical development team that is implementing a number of early stage clinical programs evaluating multiple investigational drugs for the treatment for chronic hepatitis B.
Essential Functions / Responsibilities:
- Working closely with and under the guidance of one or more Clinical Study Managers to ensure successful clinical trial planning, execution and delivery
- Creating agendas and minutes during study team meetings under the direction of a Clinical Study Manager or Head of Clinical Operations
- Performing study related administrative tasks to support the Clinical Operations Department as needed
- Tracking and reconciliation of study related materials e.g., study samples and investigational product
- Maintenance of study related tracking tools (e.g., Monitoring Visit Report Review logs, and Protocol Deviation logs).
- Assisting with the establishment and maintenance of (e)TMFs
- Assisting with quality control checks for key study related materials e.g., ICFs, protocols, study reports
- Contribution to the development of clinical trial management best practice processes and SOPs
- Contributing to department initiatives to improve the efficiency and effectiveness of the Clinical Operations group
Required Education and Experience:
- A minimum of a bachelor’s degree and/or RN Degree is required.
- A minimum of 2 or more years clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, investigational site or contract research organization is required.
Preferred Education and Experience:
- Experience of early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred.
Additional Eligibility Qualifications/Competencies
- Must have excellent teamwork, communication, decision-making and organizational skills plus a good working knowledge and understanding of FDA and EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.
- Must be proficient in Microsoft Word, Excel, MS Project, MS PowerPoint and Outlook.
- Excellent communication, organizational, negotiation and interpersonal skills required.
- Ability to prioritize and handle multiple tasks.
- The successful candidate must be flexible and adaptable to the needs of a small company.
Work Authorization/Security Clearance
- All candidates are expected to have authorization to work in the United States.
- This position may require limited collaboration with contractors external to the company.
Position Type and Expected Hours of Work
- This is a full-time position. Expected days and hours of work are Monday through Friday, 40 hours per week.
- This position is located in South San Francisco and may require a limited amount of travel.
Aligos Therapeutics, Inc. is an Equal Opportunity Employer. We do not discriminate against qualified applicants based upon any protected group status, including but not limited to race, religion, color, creed, sex (including breastfeeding and related conditions), gender identity/gender expression, pregnancy (including childbirth and related conditions), national origin, ancestry, age, marital status, military or veteran status, sexual orientation, genetic information, physical or mental disability or medical condition as defined by applicable equal opportunity laws.
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for their job. Duties, responsibilities and activities may change at any time with or without notice.
This position works in a standard office setting, in a facility that contains laboratory equipment.