Clinical Trial Assistant

Salvia BioElectronics is a medical technology company developing an implantable neuromodulation therapy for chronic migraine, currently being evaluated in clinical studies. The Clinical Trial Assistant supports the execution of U.S. clinical studies by coordinating trial operations, maintaining high-quality documentation, and ensuring compliance and audit readiness. The role partners closely with Clinical Affairs and collaborates with sites, CROs, and vendors to keep studies running smoothly.

• Maintain and update study documentation, including the electronic Trial Master File (eTMF), ensuring accuracy, completeness, and audit readiness.
• Track and manage essential documents (e.g., investigator CVs, site contracts, training logs, IRB/EC approvals, study correspondence).
• Support preparation and distribution of investigator site files, site initiation materials, and monitoring tools.
• Manage clinical device accountability documentation, including shipment records, reconciliation, and confirmations from study sites.
• Coordinate shipment and tracking of clinical trial devices and supplies.
• Assist with regulatory and IRB submissions during start-up and throughout the study lifecycle.
• Support responses to site queries and document collection.
• Perform periodic quality checks to ensure compliance with GCP, ISO 14155, 21 CFR 820, and internal procedures.
• Support audit and inspection readiness, including preparation activities and follow-up actions.
• Schedule and coordinate internal meetings, investigator meetings, and teleconferences; prepare agendas and meeting minutes as needed.
• Act as an administrative liaison between internal teams, clinical sites, CROs, and vendors.
• Support study payments, invoice tracking, and reporting activities.
• Maintain trackers, calendars, and shared documentation for clinical team operations.
• Provide administrative support to Clinical and Regulatory Affairs teams.
• Assist with document reviews, version control, and archiving of completed studies.

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field, or equivalent experience.
• 1–3 years of experience in clinical research (e.g., Clinical Trial Assistant, Clinical Coordinator, or similar).
• Strong attention to detail and commitment to high-quality documentation.
• Excellent organizational, communication, and time management skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Collaborative mindset and willingness to support cross-functional teams.

• Preferred:

  • Experience in medical device or implantable technology clinical trials.
  • Familiarity with GCP, ISO 14155, and regulatory requirements for clinical studies.
  • Experience with clinical systems such as eTMF, CTMS, or EDC.
  • Understanding of data protection regulations (e.g., GDPR) and ethical research practices.

• Location: United States (supports clinical studies in the U.S.).

• Collaborative, team-driven culture with room to grow; opportunity to contribute to innovative medical technology improving patient outcomes.

• Works closely with Clinical and Regulatory professionals and coordinates with clinical sites, CROs, and vendors.