RECORDS COORDINATOR

Major Biotech with a location in Cambridge MA is seeking a Records Coordinator in Clinical Affairs to join their team.

 

Requirements:
Associates degree (minimum), Bachelor degree preferred. 2 years experience working in a professional setting required - in a clinical research environment preferred. Good verbal and written communications, good interpersonal skills, excellent organizational skills and attention to detail required. Ability to work independently and within a matrix team environment is required. Computer literacy in Excel, Power Point and word processing programs required.

 

Description:
Assist the project team to create new Central Files Binders as new sites or protocols are added and review all sites for current regulatory documents. Assist Project team members to set-up project files, complete any outstanding documentation. and insure all documents are filed in a timely manner. Review clinical trial related documents with clinical management as requested. Prepare memos to file to report on status of documentation. Write central file procedures including a detailed description of file set-up and organization. Enforce access control and a level of accountability for the documents and files. Perform audit of the central file of active studies and insure compliance with procedures. Modify and or create site file binders to archive all available documents in a Trial Master File according to SOPs. Assist Drug Safety to archive completed trial SAE narratives.