Senior Clinical Trials Assistant (CTA)

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Senior CTA to join our Clinical Development Department to provide administrative support for all assigned clinical trials, and to provide advanced System Administrator support of the electronic Trial Master File (eTMF).
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Providing advanced System Administrator (Vault Owner) support of the eTMF under the direct supervision of the Sr. Manager of Clinical Operations, including:
    • Managing new version releases and configuration changes
    • Updating Work Instructions (WIs), document naming conventions, and training materials when needed
    • Training new users and ensure training is documented
    • Requesting new user access
    • Other eTMF-related duties, as assigned
  • Mentoring new Clinical Trials Assistants
  • Managing the set-up of studies and sites in the eTMF
  • Managing the set-up of studies and sites in the Samumed Grant Payments Application
  • Managing site non-clinical supplies including ordering supplies, initial site shipments, site re-supply requests, and in-house inventory levels
  • Managing the creation and distribution of Investigator Site File (ISF) Binders and Pharmacy Binders
  • Performing 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.
  • Uploading study documents to eTMF as directed by the Clinical Project Manager (CPM)
  • Performing Quality Control (QC) checks of original documents against electronic copies in eTMF
  • Creating folders and files study documents in paper TMFs, as required
  • Ensuring eTMF Binders are current, accurate, and complete by performing eTMF QC checks
  • Assisting with meeting set-up, including printing agendas and generating meeting minutes
  • Maintaining study documents such as Frequently Asked Questions (FAQ) Log, Master Site Contacts Tracker, Master Study Documents Tracker, etc.
  • Liaising with the Clinical Research Associate (CRA) or CPM to assist with the resolution of site questions
  • Performing study duties in adherence to the protocol, Clinical Monitoring Plan (CMP), study processes, International Conference on Harmonization Good Clinical Practice (ICH GCP), and any other study-specific requirements
  • Performing other duties as assigned

Requirements

  • Minimum 3 years of clinical research experience (CTA, CRA, or other related role)
  • Proficient in MS Office software
  • Proven ability to collaborate in a team environment and work independently
  • Excellent oral and written communication skills
  • 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