Clinical Trial Assistant- Minnesota

Minimum Requirements

• Bachelor's degree in life sciences, healthcare, or a related field.
• Basic familiarity with ICH-GCP guidelines and regulatory requirements for clinical trials.
• Strong organisational and time management skills.
• Excellent interpersonal and communication skills, both written and verbal.
• Proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Ability to work both independently and collaboratively within a team setting.
• Attention to detail and a commitment to maintaining high-quality work.

Job Requirements

• Study Start-Up Support:
  Assist with the development of clinical trial materials, e.g. trial master file build, patient binders, filing.
  Assist the clinical team with the organisation and execution of site initiation visits, where appropriate.
• Regulatory and Ethics Submissions:
  Support the preparation and submission of regulatory documents where appropriate and with supervision.
  Assist with ethics committee submissions under supervision of CRA or higher, ensuring compliance with applicable guidelines.
   
• Site Coordination and Communication:
  Communicate and coordinate with study sites regarding study shipments of binders and medical devices, including tracking information and record keeping
  Assist with the collection, review and filing of essential documents from study sites.
  Attend co-monitoring visits with a (Senior) Clinical Research associate or higher clinical staff member for hands-on training
   
• Study Material Preparation and Review:
  Assist with the preparation of documents and study-related materials under supervision of CRA or higher
  Perform regular document quality control checks.
• Data Management:
  Support the study team with data entry and data cleaning activities under supervision of CDM or higher
  Assist with Electronic Data Capture (EDC) system validations under supervision of CDM or higher.
• General Administrative Support:
  Assist with the preparation of presentations and tools for internal and external stakeholders.
  Perform other administrative tasks as assigned by CRA, Project Lead (PL) or other team members.
  Attend project meetings to take minutes, actions and distribute to PL.
• Professional Development:
  Stay current with industry trends, best practices, and regulatory updates through continuous learning and professional development opportunities.
  Attend relevant training courses, workshops, and conferences to enhance job-related skills and knowledge.
  Share acquired knowledge and expertise with team members to support a culture of continuous improvement within the organization.
   
• Occupational Health and Safety:
  Adhere to Mobius Medical's health and safety policies and procedures to maintain a safe working environment for all employees.
  Comply with OH&S legislation and operate in accordance with established OH&S practices and procedures.
  Promote a culture of safety awareness within the clinical trials team and study sites.
  Identify and report potential hazards, incidents, and safety concerns to the appropriate personnel in a timely manner.
  Complete required health and safety training to ensure compliance with company and regulatory requirements.