Senior Study Coordinator
5 days ago
Job Description
Job Level & compensation offered may vary depending on candidates' experiences and competencies.
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.
- Participates in and is responsible for team report quality peer review
- Leads aspects of communication and interaction with study team, other departments and clients as applicable.
- Serve as the primary contact in communication and interaction with other departments and clients as applicable.
- Proven ability to plan, prioritize and manage workload and multiple responsibilities.
- Demonstrated ability to independently use project tracking systems as appropriate.
- Maintains well documented, organized and up-to-date study files including study schedule, protocol and correspondence as applicable.
- Demonstrated ability to independently lead study progress monitoring
- Serves as a backup PI/SD on project management tasks
- Schedules study phases in coordination with SD/PI and lab operations.
- Ability to lead pre-initiation and other study related meetings as required.
- Proven ability to manage increasingly complex projects and study designs and/or increased study load.
- Demonstrated capability to manage work for key clients.
- Independently owns and manages process improvement initiates, or non-study related projects
- Learns to serve as a backup to management team with regards to non-personnel related management responsibilities.
- 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 and is able to lead routine client visits as requested.
- Participates in the training of new team members
- 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.
- Bachelor of Science (BS) degree in science or related field.
- Experience may be substituted for education.
- Ability to utilize word processing software, database, spreadsheet, and specialized software.
- Minimum of 5 years of related experience.
- Excellent communication, presentation, and interpersonal skills.
- Excellent attention to detail.
- Ability to prioritize and manage time.
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