Our client is a radiopharmaceutical company developing precision oncology therapeutics and complementary diagnostic imaging agents. The Company’s leading alpha-particle radiotherapies are designed to deliver powerful alpha radiation specifically to cancer cells utilizing specialized targeting peptides. They are also developing complementary diagnostics that utilize the same targeting peptide which provide the opportunity to personalize treatment and optimize patient outcomes. This "theranostic” approach enables the ability to see the specific tumor and then treat it to potentially improve efficacy and minimize toxicity associated with many other types of cancer treatments.

JOB DESCRIPTION

This is an exciting opportunity to be a part of a busy clinical stage radiopharmaceutical startup developing world class theranostics for Oncology patients. As a Clinical Trial Assistant (CTA) you are assisting the clinical research teams with a range of administration activities and providing project tracking support.

RESPONSIBILITIES

Provide general administrative support to the Clinical Operations and Project Management Departments
Assist the Clinical Operations teams with ongoing conduct of studies and completion of all required tasks to meet project and corporate goals.
Attend meetings to assist the Clinical Operations Lead and project team with e.g. internal and/or external meeting coordination, activities preparation and generate meeting minutes.
Be the super user for the VMT electronic Trial Master File (eTMF) system and be responsible for tracking eTMF progress for VMT projects
Assist project teams and Project Management Department with trial progress tracking for senior management reporting
Assist in the production of slide presentations
Be familiar with ICH-GCP, FDA and appropriate regulations, and relevant VMT SOP’s
Set up, collect, register, organize and maintain clinical study documentation including preparation for internal/external audits, final reconciliation and archival according to GCP guidelines
Coordinate ordering/dispatch and tracking of study materials (e.g. lab supplies, equipment supplies, forms) as appropriate.
Organize data collection forms and other study materials i.e. log in, tracking, quality control as appropriate for the study, for the VMT Expanded Access Program (EAP)
Assist in the tracking and distribution of correspondence and reports
Coordinate document translation
Other duties as assigned

QUALIFICATIONS

Bachelor degree, preferably in a Life Science
Knowledge of GCP, FDA and ICH guidelines and medical terminology
Research or health care related academic or work experience preferred
Strong organizational skills, ability to manage multiple tasks with meticulous attention to detail
Clear written and verbal communication skills, in English
Excellent computer literacy and application skills (e.g. Microsoft Word, Excel, PowerPoint, Outlook, BOX)

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Clinical Trial Assistant