Study Start-Up Specialist

Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next-generation biologics from concept to clinic.SummaryFortvita is seeking a dynamic and experienced Study Start-Up Specialist (SSU) who will be responsible for managing and coordinating all site start-up activities for oncology clinical trials, ensuring timely initiation and regulatory compliance. 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.ResponsibilitiesSite 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.QualificationsRequiredBachelor'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.PreferredExceptional 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.Compensation and Benefits Include:Competitive base salary, bonus, and equity for all employees.Actual compensation may vary depending on factors such as location, skills, experience, and performance.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.Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited.We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees.Additional Legal DisclaimersApplicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire.Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs.Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita's Human Resources team at hiring@. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.

Created: 2025-10-02