Job Description

learn to perform and manage activities related to technical data compilation and proofing and use of generic documents in compliance with appropriate protocol, Standard Operating Procedure (SOP), regulatory agency guideline, and client requirements in a timely, efficient, and quality manner. Take on DC-related team leader responsibilities, as appropriate (i.e. shipping calendar maintenance, process improvement projects, etc.). Mentor and/or train new DCs. Learn basic study document preparation/maintenance (i.e. prepare standard study protocols from outlines; prepare basic report shells for study directors/SCs to write in). Learn the job duties of the associate DC and more around knowledge of the scheduling tools, etc. Reads and understands study protocols, sample analysis outlines, amendments, regulatory requirements, and SOPs/ as they pertain to basic data retrieval and compilation from electronic systems (i.e. Tox Reporting, etc.). Gains familiarity and understanding in the use and preparation of generic document templates Gains familiarity and understanding in the use and preparation of client-specific requirements as they pertain to client document deliverables (protocols/reports) Works with Study Coordinators to assist in the preparation of study protocols and reports within client-specific requirements and/or the incorporation of contributing information into study reports. Learns to proof shipping paperwork prepared by others. Takes on DC team leader responsibilities and acts as a mentor/trainer for new DCs, as appropriate/applicable Learns and successfully performs report to data QC of at least two study types. Other duties as assigned Experience: Minimum 2 years of experience required