- Location
- Tampa, FL
- Type
- Full-time
- Department
- Healthcare
- Education
- Bachelor
- Source
- RecruiterFlow
Description
"At Mobius, we only hire the best of the best. Our people are the primary reason for our success and the first pillar of our core values. As a leading CRO managing clinical trials across the USA, Australia, and New Zealand, we support a diverse portfolio of global and local clients across all phases of development and an array of therapeutic goods. We are committed to supporting our partners through every step of the clinical project journey, from rapid start-ups and comprehensive monitoring to precise data management, in-house EDC, and expedited study close-out."
Job Description
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.
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.
Location
- Minnesota (Minneapolis preferred), open to near locations
Compensation:
- Competitive base salary, depending on experience
- Benefits: Medical, dental, vision – company pays 70% of the premium
- 160 hours of PTO and 48 hours of sick leave annually
- 401k match 4%
Skills
GCPExcelClinical TrialsCompliance
