Clinical Trial Assistant - Documentation Specialist

Join us in helping patients with rare diseases. At Egetis Therapeutics we challenge the status quo for the benefit of those in need. We offer an open, positive and supportive culture where everyone can be their best. Through trust, we work seamlessly across functions. As an employee you are empowered and encouraged to have an entrepreneurial spirit, enjoying an organization with conscious and efficient decision-making. We also take pride in having a great working climate!

Our vision is to bring unique life-improving therapies to patients with rare diseases. Egetis Therapeutics currently has two drug candidates in late-stage clinical development, and we are continuously seeking opportunities to grow our pipeline. We are now on an exciting journey to establish our own teams for product launches in Europe and North America.

We are committed, courageous, and collaborative people. Become a part of our inspiring environment. We care for the rare!

Brief description of the position

The Clinical Trial Assistant role is responsible for supporting the clinical team in all activities from set up to completion of clinical studies and projects as directed. May act as a central contact for the clinical team for designated project communications, correspondence and associated documentation including CRO study trial master file oversight activities. Perform administrative tasks to support team members with clinical trial execution as directed, and general “day-to-day” administrative tasks to support clinical team members.

The role is a full time position, based in our centrally located office in Stockholm. We are also open to discussing part time solutions.

Responsibilities

• To assist the Clinical Development teams in completion of all required tasks to meet departmental and project goals and support in ongoing conduct of studies.
• To assist project teams with study specific documentation and guidelines as appropriate.
• To set up, organize and maintain clinical study documentation including preparation for internal/external audits, final reconciliation and archival.
• To assist in quality control of clinical study documentation.
• Ensure accuracy, quality and integrity of internal and clinical study documentation and adherence to record retention policies and regulations.
• Maintain central registry of contact information for clinical sites, CROs, vendors and support and facilitate correspondence
• Contribute to departmental development and review of study standard operating procedures (SOPs)
• Assist in coordination of CRO and Vendor payments, tracking of payments and accruals, if applicable.
• Arrange/support internal/external meetings relating to clinical study activities, such as kick-off meetings with vendors, clinical expert meetings and investigator meetings
• Provide clerical support and administrative activities for project team (e.g., proofreading and editing correspondence).
• Coordinate document translation through vendors.
• To assist in the production of slides, etc., as needed for project, departmental, sponsor and/or business development presentations.
• Responsible for filing and tracking of Consultancy contracts
• Other administrative duties as assigned by Head of Clinical Development or CMO

You report to the Head of Clinical Development. This position has no direct reports.

Competence requirements for the position (education and experience)

• Required education: Certification in an allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology) or long-term experience as a CTA
• Experience in clinical research area
• Experience with document management systems and quality review of documents
• Knowledge of clinical terminology required
• Must have good organization skills, comfortable multi-tasking in a fast-paced small company environment and able to adjust workload based upon changing priorities
• Be a team player
• Highly organized and process oriented
• Understanding of ICH GCP and appropriate regulations
• Good written and verbal communication skills.
• Fluency in local language and good knowledge of English language.
• Computer literacy: e.g. Microsoft Word, Excel, PowerPoint, Outlook