Clinical Trial Assistant

About Soleno Therapeutics, Inc.

Soleno Therapeutics, Inc., based in Redwood City, California, is a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, including Prader-Willi syndrome (PWS).

At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are — it is in our chromosomes — and our team is made up of exceptional colleagues whose collective efforts are woven together to deliver meaningful outcomes, both professionally and for those living with PWS.

We value collaboration, integrity, and respect. These characteristics have allowed us to forge strong, authentic bonds with the caregivers, patients, health care professionals (HCPs), and community members we serve. We are proud to work alongside them every step of the way.

Our employees are our most important asset, and we are looking to expand across many functions during this important and pivotal time. We encourage you to join us in making history. We all share the most important goal of bringing solutions to the PWS community. They are waiting.

Summary of Job (brief description)

We are seeking a highly motivated individual to join Soleno Therapeutics as a Clinical Trial Assistant responsible for providing support to clinical trial teams in site management and other trial-related activities, including trial start-up, interim monitoring, and closeout activities in accordance with clinical standard operating procedures (SOPs), protocols, the International Conference on Harmonisation Good Clinical Practice (ICH GCP) / Code of Federal Regulations (CFR).

Responsibilities

• Provide high quality assistance supporting clinical trials according to applicable regulatory requirements and SOPs within budget and timelines.
• Prepare, ship, track, and manage inventory of trial-related supplies.
• Assist in preparing materials for investigator and team meetings, trial-specific manuals, etc.
• Perform various job functions including but not limited to tracking study specific documents, i.e. regulatory documents, enrollment and site activation, sample tracking, TMF maintenance, etc.
• Contribute to the development of trial-specific tools.
• Coordinate meetings and take meeting minutes as applicable.
• Other duties and assignments as requested for the overall performance of the function and Company.

Qualifications

• BS/BA in a relevant scientific discipline is preferred.
• Minimum 0-2 years related experience, preferably in the pharmaceutical industry or equivalent.
• Knowledge of applicable regulatory guidelines (i.e. ICH and GCP) is strongly preferred.
• Possess a general understanding of clinical trial and drug development process.
• Strong attention to detail and meticulous follow-through.
• Proficiency in Microsoft Outlook, Word, PowerPoint, and Excel.
• Ability to prioritize multiple tasks, plan proactively, and accomplish goals using well-defined instructions and procedures in a fast-paced environment.
• Exceptional oral, written, and interpersonal skills.

Salary Range: $70,000 - $90,000

(Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the location where this position may be filled.)