Remote Clinical Trial Assistant

Summary

Join MindMed, a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. We are seeking a Clinical Trial Assistant to help administratively manage, plan and scale clinical operations in support of the execution of our clinical research studies.

Requirements

• At least 2 years of clinical trial administration experience in a Pharmaceutical or Biotech company
• Bachelor’s degree or equivalent combination of education/experience in science or health-related field
• Experience in Psychiatry and addiction medicine preferred
• Working knowledge of GCP/ICH guidelines and the clinical development process, understanding of drug development from pre-IND through NDA
• Past experience in development of tools and other tracking documents that support clinical research
• Strong working knowledge of MS Project and developing Gantt charts
• Advance knowledge of MS Excel
• Excellent oral, written, and communication skills required
• Problem-solving and strategic planning skills
• Excited by innovative ideas in clinical research space
• Self-motivated, resourceful with getting the job done attitude in a fast-paced team environment
• Engaging, empathetic and dynamic personality; ability to understand the problems of others and delight in finding solutions

Responsibilities

• Establishes, performs quality control, maintains, and archives the Trial Master File (i.e., electronic folder set-up, filing, tracking, archiving) in compliance with DIA Reference Model, SOPs, ICH and GCPs
• Performs TMF quality reviews for both in-house and CRO-led trials
• Coordinates distribution of documents and equipment/materials to sites as well as monitors, central/core laboratories and CROs
• Collects, tracks and reviews regulatory documents and notifies sites, monitors or CRO of missing or expired documents
• Develops and maintains spreadsheets and other documents to track critical study milestones
• Tracks and reports on project or study information regarding subject and site status, metrics, lab sample shipments and discrepancies, and other parameters as appropriate
• Prepares or assists with the preparation and review of study-related materials as it pertains to CTA processes (e.g., study reference manual, clinical trial material requests, and Investigator Site File)
• Participates in team review of data listings and clinical study reports. Submits required documentation for appendices of clinical study reports or for inclusion into a regulatory filing
• Organizes study information on the shared file drives and retrieves information from the central/core laboratories or CRO portals
• Assists Clinical with oversight of third-party vendors and other clinical operations tasks
• Performs assigned administrative activities in support of clinical trials from design to completion
• Participates in the planning and conduct of central/core laboratory, CRO and study-related meetings; creates agendas and draft minutes as appropriate
• Sets up and attends meetings, takes meeting notes, and updates and distributes meeting minutes
• Organizes and helps plan meetings. May interact with meeting planners and travel agents
• Communicates to internal and external team members (e.g., vendors, site personnel, and consultants)
• Coordinates the distribution of communications to all sites (e.g., questionnaires, newsletters, mass mailings, IND safety reports, Investigator’s Brochures, etc.)
• Assists the Clinical Operations Lead with tracking of vendor or site invoices and ensures accurate accrual records are kept with guidance from the Senior Clinical Trial Associate as needed
• Maintains up-to-date knowledge of current regulations and guidelines to ensure compliance
• Provides general administrative support to the clinical team as assigned
• Processes forms, requests for information by the team, and requests to obtain information from vendors and investigative sites
• Performs other duties as assigned
• Responsible for managing general department administrative tasks as needed (up to 20%)

Benefits

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!