Clinical Trials Assistant
Under general guidance from the Director of Clinical Operations and the Clinical Trial Manager, you will support the Clinical team responsible for management of multiple clinical trials (all phases), and assure compliance with GCP and ICH guidelines.
Assist with all phases of clinical study activities (start-up, maintenance, close-out).
Create and maintain all study trackers (contact lists, study status trackers, enrollment, etc).
Provide clerical support and administrative activities for project team (e.g., assemble study documents, shipment of study materials, proofreading and editing correspondence, etc.)
Assist the project team in preparation and distribution of study documents (i.e. consent form, study reference manual, regulatory binder, study updates, etc.)
Coordinate Regulatory Binders, Study Reference Manual and other supply shipments to sites.
Coordinate and distribute mass mailings.
Process and distribute Subject Qualification Discussion Forms/Protocol Deviation Forms.
Schedule and set up study team and vendor meetings. Draft meeting minutes/distribute final minutes.
Assist project team with Investigator Meeting coordination and preparation and draft meeting minutes.
Assist with submission of documents to the Clinical Trial Master Files.
Assist with quality and validity of clinical trial data.
Establish collaborative relationships with colleagues in Clinical Development, Regulatory Affairs and throughout the Company.
Perform additional tasks and duties as assigned.
Bachelor degree in a Four-year degree in a biological or physical life science or a nursing degree or equivalent preferred. Minimum 1-year experience in a clinical department of a biotech/pharmaceutical company or completion of Clinical Research Certificate. Must have good organization skills, be a team player, function independently and be able to interact comfortably with company personnel as well as vendors and investigational sites. Knowledge of clinical terminology required. Computer proficiency and GCP knowledge required.