Clinical Research Associate
- Experience 0-5 Years
- Category Research
- Location South San Francisco, CA
Alios BioPharma, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Clinical Research Associate to be located in South San Francisco, CA. This position may also require up to 15 % travel
Johnson & Johnson's Family of Companies are dedicated to addressing and solving the most important unmet medical needs of our time, including: oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop sustainable, integrated healthcare solutions by working side-by-side with healthcare stakeholders, based on partnerships of trust and transparency.
Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.
The Clinical Research Associate will report directly to the Head of Clinical Development and will be responsible for the operational implementation of one or more clinical trial programs. This individual will be a key member of a small clinical development team that is implementing a number of early stage clinical programs evaluating antiviral investigational drugs.
The Clinical Research Associate will:
• Develop and execute high-quality, realistic, cross-functional, clinical trial plans using best practice management standards and methodologies.
• Identify and select Service Providers (SPs) and clinical sites.
• Develops and disseminate Requests for Proposals from Service Provider’s and will manage Service Providers including training and oversight, and serves as the primary point of contact for SPs.
• Draft and coordinate the review of study-related documents including protocols, informed consent forms, case report forms, monitoring plans, investigator brochures, and clinical study reports.
• Maintain program timelines, develops study budgets, and coordinates review of data listings and prepares interim/final clinical study reports.
• Contribute to development of abstracts, presentations, and manuscripts and may contribute to the development of clinical trial management best practice processes and SOPs.
•A minimum of a Bachelor’s Degree and/or RN Degree is required.
•A minimum of 3 years clinical monitoring and clinical operations experience within a pharmaceutical, biotechnology, or contract research organization is required.
•Experience of early clinical development, particularly with antiviral or anti-infectious disease compounds is preferred.
•Significant experience of Service Provider selection and management is preferred
•Must have in depth knowledge of the Code of Federal Regulations related to clinical research, ICH GCP guideline and other applicable regulations and practices is required.
•Working knowledge, understanding and application of principles, concepts and practices of clinical research, experimental design and statistical analysis is required.
•Ability to prioritize and handle multiple tasks and to facilitate and resolve cross-functional activities and issues required.