Clinical Studies Coordinator

DiaSorin•Stillwater, MN

12d•$73,000 - $89,000•Onsite

About The Position

Provide support to new assay/product development and clinical studies by coordinating and compiling the clinical data, perform administrative tasks as part of clinical project teams to support the completion of clinical trial/regulatory documentation and processes. Support applicable regulations including ISO, Local, State, and/or Federal requirements. This role is onsite at our Stillwater, MN location

Requirements

Bachelor's Degree and one to two years related experience and/or training; or equivalent combination of education and experience.
Competent in MS Excel, Access and Word. Familiarity with Google Suite
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence
Ability to add and subtract two digit numbers and to multiply and divide with 10’s and 100’s. Ability to perform these operations using units of American money and weight measurements, volume, and distance
Ability to apply common sense understanding to carry out instructions furnished in written, verbal, or diagram form
Ability to deal with problems involving several concrete variables in standardized situations

Responsibilities

Build and maintain clinical regulatory binders for clinical sites.
Maintain clinical sample and device accountability; including shipments and logs.
Maintain clinical study databases for internal and external clinical sites. Identify data discrepancies and query sites as appropriate.
Coordinate regulatory binder, monitoring visits (remote and onsite) and data queries with CRO and clinical sites, as appropriate.
Ensure GCP study conduct throughout the study.
Coordinate and file study and site document archives.
Train and work with internal and external team members, as requested for the completion of clinical activities
Perform assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.
Performs other duties as assigned