Clinical Trial Assistant

Salvia BioElectronics is a medical technology company developing an implantable neuromodulation therapy for chronic migraine and running clinical studies internationally. The Clinical Trial Assistant supports the execution of U.S. clinical studies by keeping trial documentation accurate, compliant, and audit-ready while coordinating operational and administrative activities. The purpose of the role is to enable smooth study operations and high-quality regulatory-compliant trial conduct.

• Maintain and update study documentation, including the electronic Trial Master File (eTMF), ensuring accuracy, completeness, and audit readiness.
• Track and manage essential study documentation (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 study start-up and throughout the study lifecycle.
• Support responses to site queries and document collection.
• Perform periodic quality checks of clinical documentation to ensure compliance with GCP, ISO 14155, 21 CFR 820, and internal procedures.
• Support audit and inspection readiness, including preparation and follow-up actions.
• Schedule and coordinate internal meetings, investigator meetings, and teleconferences.
• Prepare agendas and meeting minutes when required.
• Act as a liaison between internal teams, clinical sites, CROs, and vendors for administrative tasks.
• Support study payments, invoice tracking, and reporting activities.
• Maintain trackers, calendars, and shared documentation supporting clinical team operations.
• Provide administrative support for 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 focus: supporting clinical studies in the United States.
• Work involves collaboration with internal teams, clinical sites, CROs, and vendors.
• Company environment described as team-driven with room to grow and opportunity to contribute to meaningful medical technology.