- Drafts protocols, amendments, and study schedules as appropriate using study outline or client supplied information
- Reviews study compliance against protocol, SOP, and regulatory agency guidelines
- 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
- Participates in and assists SD/PI with pre-initiation and other study related meetings as required
- Proactively communicates and interacts with study team (SD’s and operational staff) to ensure key milestones are achieved
- Serves as the primary contact in communication and interaction with other departments and clients as applicable
- Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence.
- 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.
- Aids in report preparation, including tables and figures. Compiles analytical information from laboratory groups.
- Assists in interpreting and evaluating data for reports
- Participates in the peer review process for scientific reports
- 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.
- Responsible for and drives report production through finalization, including archiving of data as appropriate.
- 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.
- Maintains an awareness of the financial status of ongoing studies, including work scope changes
- Relevant degree (i.e. Life Sciences) plus 2 years of appropriate experience; relevant experience may be substituted for academic qualifications.
- Ability to utilize word processing, databases, spreadsheets, and specialized software on personal computers.
- Skilled in the use of standard laboratory equipment.
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