Clinical Trials Assistant

San Diego, Los Angeles, or Orange County, CA

  • We are seeking a responsible, dynamic, creative, and highly motivated Clinical Trials Assistant (CTA) to join our Clinical Operations Department. 
  • This is a full-time position in San Diego, Los Angeles, or Orange County.

Specific Responsibilities

  • Provides administrative support to the Clinical Operations department for all assigned clinical trials.
  • Manages the set-up of studies and sites in the electronic Trial Master File (eTMF).
  • Manages the set-up of studies and sites in the Samumed Grant Payments Application.
  • Manages site non-clinical supplies including ordering supplies, initial site shipments, site re-supply requests, and in-house inventory levels.
  • Manages 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.
  • Uploads study documents to eTMF as directed by the Clinical Project Manager (CPM).
  • Performs Quality Control (QC) checks of original documents against electronic copies in eTMF.
  • Creates folders and files study documents in paper TMFs, as required.
  • Ensures eTMF Binders are current, accurate, and complete by performing eTMF QC checks.
  • Assists with meeting set-up, including printing agendas and generating meeting minutes.
  • Maintains 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.
  • Performs other duties as assigned.
  • Performs study duties in adherence to the protocol, Clinical Management Plan (CMP), study processes, International Conference on Harmonization Good Clinical Practice (ICH GCP), and any other study-specific requirements.
  • Maintains 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.
  • Proven ability to collaborate in a team environment and work independently.
  • Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment.

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.