Clinical Documentation Specialist

Clinical Document Specialist
In this position, you will support the collection, maintenance, and archival of essential clinical trial documents (trial master files) for the Clinical Operations department, under the report of the Clinical Operations Director. To accomplish this, you will provide meaningful support to the creation, implementation, maintenance, and continued improvement of physical and electronic filing systems for the housing of essential clinical trial documents. In addition, you will contribute intellectual energy, experience, and enthusiasm to the establishment and growth of the essential trial documentation group. Duties include overseeing the regulatory document collection and submission process for assigned trials, certifying that all investigators are in compliance with 21 CFR, ICH GCP section 8, and CVT?s SOPs before drug shipment. You will liaise between in-house personnel and site and/or regional personnel within assigned trials to ensure that outstanding investigative site regulatory documents are collected, filed, and archived in compliance with regulations. This requires that you work closely and collaboratively with clinical program and project managers to ensure that all file content and format are adhered to and that essential documents are processed in a timely manner. Partnering with CVT?s clinical QA group, you will assist in conducting routine audits of clinical site files to ensure that site regulatory documents are handled appropriately.

Requirements
Four or more years of experience creating and/or maintaining clinical trial filing systems within a pharmaceutical company or CRO is a must. Expertise in ICH GCP Section 8, Microsoft Word, Microsoft XL, and other Microsoft Office Applications is essential. Familiarity with Documentum, Microsoft Access and other electronic document management systems is very desirable. Exemplary attention to detail, outstanding organizational skills, an ability to work under aggressive timelines, and effective communication are also necessary attributes of a successful candidate.

 

Please Contact: Jay VanHousen: 847-317-9544, ext. 245