Covance Study Coordinator I- BioA
Covance's BioAnalytical lab in Madison, WI is seeking a Study Coordinator I. If you have 1+ years of non-clinical study coordinator experience and are looking for a path forward to project management, then this is the position for you.
In this role, you will independently performs activities related to project management processes by coordinating activities for routine studies in compliance with appropriate protocol, Standard Operating Procedures (SOPs) and regulatory agency guidelines, in a timely, efficient, and quality manner.
Strong verbal and written communication skills are a essential, as you interface directly with our clients and well as internal project managers and lead scientists.
Duties and Responsibilities:
- Independently drafts protocols, sample analysis outlines (SAOs), amendments and study schedules with some oversight, using proposal outline or client-supplied information.
- Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
- Responsible for data table compilation including quality review oversight and data table transfer.
- Communicates and interacts with study team, other departments and clients as applicable.
- Learns to serve as the primary contact in communication and interaction with other departments and clients as applicable.
- Learns to plan, prioritize and manages own workload and multiple responsibilities.
- Learns to independently use project tracking systems as appropriate.
- Learns to maintain well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
- Learns to assist SD/PI in monitoring study progress.
- Schedules study phases in coordination with SD/PI and lab operations.
- Learns to participate in and assist Study Director/Principal Investigators with pre-initiation and other study related meetings as required.
- Learns to manage increasingly complex projects and study designs and/or increased study load.
- 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.
- Assists with routine client visits as requested.
- Performs other related duties as assigned
- Internal - Interacts with internal staff responsible for study management. In addition, interacts with internal operational and scientific personnel and the management of these areas.
- External – Interacts with clients, subcontractors, research facilities and regulatory agencies.