Sr. Clinical Trial Associate

Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems through protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $313M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.

Position Summary

The Sr Clinical Trial Associate (Sr CTA) position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies in accordance with applicable regulations, Good Clinical Practice (GCP), and Synthekine standard operating procedures (SOPs). The Sr CTA will support the Associate Director, Clinical Trials in day-to-day activities for managing clinical trial conduct. The ideal candidate will have keen attention to detail and the ability both to prioritize and handle multiple tasks effectively in a rapidly growing company environment. The role reports to the Associate Director, Clinical Trials.

Responsibilities

• Organize/maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out
• Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
• Schedule and coordinate study meetings, materials, and agendas; record and disseminate decisions and actions
• Responsible for internal meeting agendas/minutes as applicable
• Responsible for updating, maintaining, and quality control of eTMF and shared file locations
• Coordinate training for the assigned clinical study
• Coordinate and manage version control of clinical documents, prioritize multiple tasks and/or projects with limited supervision
• Support Associate Director, Clinical Trials with specific projects
• Effectively communicate with study team members and work closely to address challenges
• Liaise with contract organizations, select vendors and other suppliers of project support services to ensure clinical trial deliverables are met (i.e., contribute to documentation, processes, and set-up activities to facilitate efficient working and effective partnerships with external groups)
• Provide input on agendas, maintain meeting minutes, create materials, liaise with meeting planners, and coordinate logistics for internal or external meetings
• Track and manage inventories of clinical trial supplies

Minimum Qualifications

• BS/BA degree with 5 years of related experience
• At least one year of experience in clinical operations in Sponsor company
• Working knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures
• Working knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations
• Experience with eTMF; ability to directly apply essential document knowledge to file documents
• Effective communication, organizational and interpersonal skills
• Ability to work effectively on a team
• Proficiency in MS Excel, Word and PowerPoint. Knowledge of MS project preferred.
• Proven ability to prioritize and manage multiple tasks simultaneously
• Demonstrated ability to identify and resolve issues
• Ability to effectively manage timelines
• Participate in inter-departmental workgroups to create or enhance processes
• Strong attention to quality/detail
• Good organizational & time management skills
• Ability to work well in a changing environment

Preferred Qualifications

• At least 3 years of experience in clinical operations
• Experience with global studies, using an outsourced CRO model
• Experience in clinical drug development with knowledge of First in Human Oncology trials
• Experience with regulatory affairs, including IND/CTA submissions

The anticipated salary range for the position of Sr. Clinical Trial Associate based in our Menlo Park, CA office is $131,000 – 138,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state federal and local laws regarding pay practices.

Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).