Fortvita Biologics · 3 weeks ago
Clinical Research Associate (CRA)/ Sr. CRA
United States
Full-time
Remote
Mid, Senior Level
3+ years expFortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering. The company is seeking a dynamic and experienced Clinical Research Associate to manage and monitor clinical trial sites, ensuring compliance with study protocols and regulatory requirements while supporting site selection, initiation, monitoring, and close-out activities.
Biotechnology
No H1B
Responsibilities
Under general supervision, serve as Study Site Start-Up activities coordinator in assigned studies for investigative sites, Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables, and project timelines
Perform site selection, start-up, and activation activities according to applicable regulations, SOPs, and work instructions. Distribute completed documents to sites and internal project team members
Prepare site regulatory documents, reviewing for completeness and accuracy
Oversee the progress of clinical studies at assigned sites, ensuring accurate documentation, data integrity, patient safety, and protocol adherence. Review case report forms (CRFs) and source documents
Proactively encourage and facilitate site enrollment, helping implement tailored recruitment action plans, and providing motivational feedback and resources to site staff to maintain engagement and momentum in reaching enrollment targets
Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information
Review and provide feedback to management on site performance metrics
Inform team members of the completion of regulatory and contractual documents for individual sites
Work with the Project Manager responsible closely for the budget and contract negotiation and sign-off in a timely manner
Provide local expertise to the project team during initial and ongoing project timeline planning
Perform quality control of documents provided by sites
Maintenance of the eTMF until handed over to the site management team
Other duties as assigned
Qualification
Required
Bachelor's Degree in Scientific discipline or health care preferred
Requires 3-5 years of professional experience in Site Management
Good knowledge of, and skill in applying, applicable clinical research regulatory requirements (i.e., ICH-GCP)
Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer, iPhone, and iPad (where applicable)
Written and verbal communication skills including good command of English language
Organizational and problem-solving skills
High attention to detail and commitment to quality
Preferred
Self-motivated with a strong sense of initiative
Adaptability and ability to work in a dynamic environment
Collaborative team player with a positive attitude
High degree of professionalism and confidentiality
Benefits
Competitive base salary, bonus, and equity for all employees.
401(k) retirement plan with employer matching contributions.
Comprehensive medical, dental, and vision insurance.
Generous paid time off policy, including company holidays and floating holidays.
Company
Fortvita Biologics
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase