Fortvita Biologics · 1 day ago
Study Start-Up Specialist
Palo Alto, CA
Full-time
Onsite
Mid Level
3+ years expFortvita Biologics is seeking a dynamic and experienced Study Start-Up Specialist who will be responsible for managing and coordinating all site start-up activities for oncology clinical trials. This role serves as the primary point of contact for assigned sites during the start-up phase, working closely with investigators, regulatory agencies, ethics committees, and internal teams to facilitate efficient trial activation.
Biotechnology
Responsibilities
Site Identification and Selection: Identify and select appropriate investigational sites for oncology clinical trials, coordinating feasibility assessments and site evaluation visits
Regulatory and Ethics Submissions: Prepare, review, and submit essential regulatory documents, including study protocols, informed consent forms (ICFs), and ethics committee applications
Document Collection and Review: Collect, review, and approve essential site documents required for site activation and regulatory approval. Ensure all documents are uploaded to the electronic Trial Master File (eTMF) in a timely manner
Site Activation: Coordinate site initiation activities, including scheduling initiation visits, ensuring site personnel are trained, and providing necessary resources for study start
Stakeholder Coordination: Serve as the primary point of contact for assigned sites, resolving queries and facilitating communication between investigators, regulatory bodies, and internal teams
Timeline Management: Forecast, track, and report on site activation metrics and timelines, ensuring all sites are activated according to study schedules
Compliance and Quality Assurance: Ensure all start-up activities comply with ICH/GCP guidelines, local regulations, and sponsor SOPs. Maintain high standards of documentation and record-keeping
Contract and Budget Management: Assist with contract and budget negotiations with study sites
Training and Support: Provide training and support to site staff as needed
Issue Escalation: Identify and escalate site issues or delays to management for timely resolution
Qualification
Required
Bachelor's degree in life sciences, nursing, pharmacy, or a related field
Minimum of 3 years of clinical research experience, with a strong preference for experience in oncology trials and site start-up activities
Thorough understanding of clinical trial regulations (ICH/GCP), regulatory submission processes, and essential document requirements
Preferred
Exceptional organizational and time management skills
Strong communication and interpersonal abilities
Attention to detail and problem-solving aptitude
Ability to multitask and work independently or as part of a team
Proficiency in Microsoft Office (Word, Excel, PowerPoint, SharePoint)
Experience with oncology clinical trials and familiarity with electronic clinical trial management systems
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
Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase