Clinical Trial Assistant

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 as well as closeout activities in accordance with clinical standard operating procedures (SOPs), protocols, the International Conference on Harmonization 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.)