Clinical Trials Assistant (CTA)

San Diego, CA

  • Samumed is looking for an intelligent and enthusiastic individual to join its Clinical Development team as a Clinical Trials Assistant.
  • The Clinical Trials Assistant will provide administrative support to the Clinical Operations team across the company's ongoing clinical studies.
  • This position will be based in Samumed’s San Diego office. 

Specific Responsibilities

  • Manage the set-up of studies and sites in the electronic Trial Master File (eTMF)
  • Manage the set-up of studies and sites in the Samumed Grant Payments Application
  • Manage site non-clinical supplies including ordering supplies, initial site shipments, site re-supply requests, and in-house inventory levels
  • Manage the creation and distribution of Investigator Site File (ISF) Binders and Pharmacy Binders
  • May perform study start-up duties, including but not limited to: essential document collection and review, uploading initial site documents to eTMF, review of site Information Consent Forms (ICF) against the ICF Checklist, completion of the site IP Release Form, etc.
  • Upload study documents to eTMF as directed by the Clinical Project Manager (CPM)
  • Perform Quality Control (QC) checks of original documents against electronic copies in eTMF
  • Create folders and files study documents in paper TMFs, as required
  • Ensure eTMF Binders are current, accurate, and complete by performing eTMF QC checks
  • Assist with meeting set-up, including printing agendas and generating meeting minutes
  • Maintain study documents such as Frequently Asked Questions (FAQ) Log, Master Site Contacts Tracker, Master Study Documents Tracker, etc.
  • May liaise with the Clinical Research Associate (CRA) or CPM to assist with the resolution of site questions
  • Perform other duties as assigned
  • Perform study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, ICH-GCP and any other study-specific requirements
  • Maintain compliance with company policies and procedures

Requirements

  • 4 year life sciences or health care related degree
  • Proficient in MS Office software
  • Excellent verbal and written communication skills

Please submit your resume or additional inquiries to apply@samumed.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.