Performs activities related to the Study coordinator process by coordinating activities for routine studies in compliance with appropriate protocol, Standard Operating Procedure (SOP) and regulatory agency guidelines. And analyzes biological or chemical samples and/or develops/validates methodologies for various compounds and components in compliance with appropriate standard operating procedures (SOPs) and regulatory agency guidelines.
A. Essential Job Duties:
Independently drafts protocols; sample analysis outlines (SAOs), amendments and study schedules with some oversight, using proposal outline or client-supplied information.
Reviews study compliance against protocol, SOP and regulatory agency guidelines.
Communicates and interacts with study team, other departments and clients as applicable.
Assists in the development and maintenance of standard report/table formats as needed.
Plans, prioritizes and manages own workload and multiple responsibilities.
Independently use project tracking systems as appropriate.
Learns to improve processes to increase the efficiency of daily/routine procedures and reporting methods.
Participates in and assists Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
Ability to manage increasingly complex projects and study designs and/or increased study load.
Assists in interpreting and evaluating data for reports.
Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
Reviews QAU report audits. Submits audit responses for approval as appropriate. Follows up with appropriate personnel to ensure that all necessary report/raw data clarifications are completed within specified timelines.
Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all necessary report/raw data clarifications are completed.
Responsible for report production processes through finalization, including archival of data as appropriate.
Assists SD/PI in monitoring study progress.
Schedules study phases in coordination with SD/PI and lab operations.
Maintains an awareness of the financial status of ongoing studies, including work scope changes.
Performs other related duties as assigned.
