Clinical Trial Assistant- Minnesota
About The Position
The Clinical Trials Assistant (CTA) role at Mobius Medical is an entry level position into a career in clinical research. The CTA is responsible for providing administrative and organisational support under direction to the clinical trials team. This includes assisting with study start-up activities, communicating with study sites, assisting with monitoring activities, and supporting data management. The CTA will work closely with the Clinical Project Manager and other team members to ensure compliance with ICH-GCP guidelines, as well as national and international regulations. In a training capacity, the CTA will be mentored by colleagues and delegated project-related tasks as part of hands-on training.
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.
Responsibilities
- 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.
- 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.
- 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.
- Assist with the preparation of documents and study-related materials under supervision of CRA or higher.
- Perform regular document quality control checks.
- 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.
- 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.
- 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.
- 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.
Benefits
- Medical, dental, vision – company pays 70% of the premium
- 160 hours of PTO and 48 hours of sick leave annually
- 401k match 4%
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
