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

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  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.
  
  


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  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.
  
  


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  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.
  
  
   
  
  


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  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.