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.