Project Coordinator I

Primary Purpose:

To support Principal Analytical Investigators (PAIs) with sponsor specific sample analysis projects from initiation through completion in real-time. The responsibilities of this role include building study designs, master assays, sample analysis runs and reassay runs in Watson. Additional responsibilities include communicating with sponsors, generating data for QC and QA review, monitoring project deliverables and supporting laboratory operations.

Job Duties and Responsibilities:

• Ensure sample analysis is executed as scheduled by building in Watson: study designs based on study protocols, master assays based on approved methods and sample analysis runs.
• Understand all internal and external study components included but not limited to study protocols or study design, method validation/sample analysis plans and data transfer agreements.
• Support sample management accessioning by importing sponsor provided barcodes from electronic manifests.
• Compile data tables with quality review oversight and complete data table transfer. • Generate sample analysis results data tables from Watson as scheduled to meet both internal and external stakeholder deliverable deadlines.
• Support sponsor driven special requests, including but not limited to sample inventory reports, custom data requirements and sample reconciliation activities. • Review final data for completeness and folders are routed to the assigned PAI.
• As needed, draft sponsor driven communications and documentation, including but not limited to meeting minutes and data transfer agreements.
• Communicate and interact with study team, other departments, and clients as applicable.
• Learn to serve as the primary contact in communication and interact with other departments and clients as applicable.
• Learn to plan, prioritize, and manage own workload and multiple responsibilities.
• Learn to independently use project tracking systems as appropriate.
• Ensure documentation is organized and up-to-date including protocol and correspondence as applicable.
• Learn to assist PAI in monitoring study progress.
• Learn to participate in and assist PAI with pre-initiation and other study related meetings as required.
• Schedule study phases in coordination with PAI and lab operations.
• Assist with resolution of QA Audit findings and associated corrective actions.
• Learn to manage increasingly complex projects and study designs and/or increased study load.
• Assist with routine client visits as requested.
• Peer review other PC colleagues' work.
• Perform other related duties as assigned.

Other responsibilities dependent on the site include:

• Draft analytical plans, amendments, and study schedules with oversight, using proposal outline or client-supplied information.
• Construct sample analysis folders for extraction and instrumentation.
• Ensure that study specific supplies, including but not limited to reference material, internal standard, standard calibrators and QCs, instrument columns, specialized plates and control matrices, etc. are in stock and within expiry (where applicable).

Working Conditions:

• Office environment with occasional laboratory exposure
• Essential physical requirements include going up/down stairs, typing, and sitting or standing for long periods
• Physical effort requirements are moderate (ranging from sedentary to lifting boxes up to 10-15 pounds)
• Occasional long hours and/or weekends during peak production cycles and/or staff absences

• Working Conditions:

• Office environment with occasional laboratory exposure
• Essential physical requirements include going up/down stairs, typing, and sitting or standing for long periods
• Physical effort requirements are moderate (ranging from sedentary to lifting boxes up to 10-15 pounds)
• Occasional long hours and/or weekends during peak production cycles and/or staff absences
• No travel requirements unless attending off-site training