Clinical Trial Assistant

Department

Clinical Affairs

Location

San Diego, CA

Job Type

Full Time

ID #

1234567


What We’re Looking For

Cue Health Inc. is seeking to hire a full-time Clinical Trial Assistant.  The Clinical Trial Assistant (CTA) administers, supports, maintains and executes logistical aspects of clinical trials according to Good Clinical Practice and relevant Standard Operating Procedures. The CTA will assume an active role within Cue Health’s Clinical Affairs team and interface with the clinical study teams at contracted CRO and external clinical study sites. This position will report to Cue Health’s Associate Director of Clinical Affairs.

Responsibilities:

  • Provide clinical study administrative support to Cue Health’s Clinical Affairs team 

  • Create, manage, and audit clinical trial master files and investigator site binders

  • Prepare, distribute, track and process incoming clinical study documents including data collection forms; perform final reconciliation and archival of study documents

  • Review of study files for accuracy and completeness including preparation for internal/external audits

  • Prepare, handle, and distribute lab kits and clinical study supplies; create and maintain tracking information

  • Assist with meeting coordination and preparation activities; ability to take, finalize, and file meeting minutes

  • Handle, ship, and receive biological specimens

  • Perform literature searches for study-specific guidance documents and any other necessary references

  • Maintain a working understanding of current applicable regulations such as FDA Code of Federal Regulations, GCP, ICH GCP, SOPs, WI and guidance documents

  • Demonstrate commitment to the implementation and effectiveness of Cue’s Quality

  • Management System per ISO, FDA, and other regulatory agencies

  • Perform additional tasks as requested to meet company goals

Requirements:

  • BA or BS degree in science or related field preferred

  • A minimum of 2 years of experience in clinical research or related field

  • Previous experience in creating, managing, and auditing clinical trial master files and investigator site binders is highly preferred

  • Knowledge of applicable clinical research regulatory requirements (ie, GCP and ICH)

  • Strong written and verbal communication skills

  • Meticulous attention to detail

  • Effective organizational and time management skills; ability to manage multiple assignments and changing priorities

  • Demonstrated ability to establish and maintain effective working relationships with coworkers, managers, and contractors

  • Demonstrate professionalism with all internal and external contacts

  • Proficient with Microsoft Office software: Word, Excel, PowerPoint, and Visio

  • Experience with electronic document storage systems (ie, Box or Dropbox)

  • Familiarity with Clinical Research Associate (CRA) role including assisting with CRA tasks such as site monitoring visits

  • Ability and willingness to safely handle, receive and ship biological specimens


As part of Cue, you will:

Be instrumental in assuming an active role within Cue Health’s Clinical Affairs team and interface with the clinical study teams at contracted CRO and external clinical study sites.


Where you’ll work

You will work in a modern open office located in Sorrento Valley in San Diego, CA, with a lot of natural light. As an early employee your contribution will set the pace and have an impact in Cue’s future. Your work and ideas will be valued and respected, and we hope you will find enjoyment working with a great team on such an innovative device.


Perks within Cue culture

  • New computer equipment

  • Unlimited snacks

  • Competitive salary

  • Stock options