Assist Study Coord, Metabolism

<h2>Job Overview:</h2><ul><li><span style="font-size: 11.0pt;">Drafts protocols, amendments, and study schedules as appropriate using study outline or client supplied information</span></li><li><span style="font-size: 11.0pt;">Reviews study compliance against protocol, SOP, and regulatory agency guidelines</span></li><li><span style="font-size: 11.0pt;">Prepares study schedules based on input from Study Director (SD)/Principal Investigator (PI), places information into databases and communicates work plan to laboratory personnel and support groups, as applicable</span></li><li><span style="font-size: 11.0pt;">Participates in and assists SD/PI with pre-initiation and other study related meetings as required</span></li><li><span style="font-size: 11.0pt;">Proactively communicates and interacts with study team (SD’s and operational staff) to ensure key milestones are achieved</span></li><li><span style="font-size: 11.0pt;">Serves as the primary contact in communication and interaction with other departments and clients as applicable</span></li><li><span style="font-size: 11.0pt;">Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence.</span></li><li><span style="font-size: 11.0pt;">Assists SD/PI in monitoring in-life and analytical phases of studies, if applicable and review of study compliance with protocol, SOPs and regulatory guidelines.</span></li><li><span style="font-size: 11.0pt;">Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.</span></li><li><span style="font-size: 11.0pt;">Assists in interpreting and evaluating data for reports</span></li><li><span style="font-size: 11.0pt;">Participates in the peer review process for scientific reports</span></li><li><span style="font-size: 11.0pt;">Reviews QAU report audit sand client comments with SD/PI or appropriate laboratory group. Submits audit responses for SD/PI approval. Ensures that all necessary report/raw data clarifications are completed.</span></li><li><span style="font-size: 11.0pt;">Responsible for and drives report production through finalization, including archiving of data as appropriate.</span></li><li><span style="font-size: 11.0pt;">Prepares for and participates in routine client visits under direction of the SD/PI. Learns to host routine client visits and interacts/communicates with client as necessary.</span></li><li><span style="font-size: 11.0pt;">Maintains an awareness of the financial status of ongoing studies, including work scope changes</span></li></ul><h2>Education/Qualifications:</h2><ul><li><span style="font-size: 11.0pt;">Relevant degree (i.e. Life Sciences) plus 2 years of appropriate experience; relevant experience may be substituted for academic qualifications.</span></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 11.0pt;">Ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers.</span></li><li><span style="font-size: 11.0pt;">Skilled in the use of standard laboratory equipment.</span></li></ul>