Study Coordinator I - Flow Cytometry

TD2

Bothell, WA

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JOB DETAILS

SKILLS

Biotech and Pharmaceutical, CAP - Certification Authorization Professional, Clinical Trial, Communication Skills, Contract Research Organization (CRO), Data Entry, Detail Oriented, Develop and Maintain Customers, Documentation, Establish Priorities, GLP (Good Laboratory Practices), Genomics, Mathematics, Medical Products, Medical Tests, Microsoft Excel, Microsoft Office, Microsoft Outlook, Microsoft SharePoint, Oncology, Organizational Skills, Pre-Clinical Development, Presentation/Verbal Skills, Reconciliation, Regulations, Regulatory Requirements, Standard Operating Procedures (SOP), Systems Maintenance, Time Management, Translational Research, Vlookups

LOCATION

Bothell, WA

POSTED

4 days ago

We are the leading oncology CRO, developing novel treatments for patients that need them most. Our team is fully dedicated to oncology - it is all we do - combining innovation and expertise to quickly move medicines from preclinical development into clinical trials. Adaptive and forward-thinking - we guide our client's therapy through the most critical development milestones from the lab to planning their regulatory and clinical strategy. Our ultimate goal? To help patients. Position Summary: The Study Coordinator - Flow Cytometry; performs scientific data table creation, data entry and review for preclinical and/or clinical Flow Cytometry based studies. Coordinates sample information between client and laboratory personnel and archives study data. Operates within a Good Laboratory Practice (GLP) / Washington State Medical Test Site/ CAP Accredited environment Essential Functions: * Creates Excel templates for scientific data entry in presentation ready format for study sponsors with guidance from supervisor and senior team members. * Performs the data entry of scientific data into Excel tables. * Ability to adapt to new tasks while maintaining awareness of previously assigned responsibilities. * Participate in maintaining filing system of binders and study related data. * Verification of sample receipt; this includes but is not limited to verification of incoming shipments, documentation in database, making lab team aware of unscheduled samples, and filing appropriately. * Communicate with sponsors or scientific colleagues via email or face-to-face. * Handles data queries from sponsor representatives and ensures resolution of inconsistencies with guidance from supervisor and senior team members. * Coordination of study specimen reconciliations; includes organization of the issues, documentation, sponsor correspondence, resolutions, and internal communication of the resolution. * Review and verification of scientific data including, but not limited to, study/project related forms and data tables. * Preparation of study archive after project is complete, includes scanning documents, indexing, verification, and electronic data copies. * Communicate and plan archive duration for long-term storage and disposition, as requested by head archivist. * Adhere to regulatory requirements, protocols, and standard operating procedures at all times. * Performs other duties as assigned. Job Requirements: * Associates or Bachelor's degree in a scientific related field * 0-1 years' experience as a Study Coordinator or in a related role is preferred. Required Specialized/Technical Skills: * Strong computer and math skills, including proficiency in the use of Microsoft Office and its applications (Outlook, Teams, SharePoint, and more). * Proven strong understanding of Excel and its functions, such as Pivot and Vlookup. * Strong attention to detail, highly organized, and able to set priorities and meet deadlines in a fast-paced environment. * Good communication skills, both oral and email. * Experience in Good Laboratory Practices and CAP regulations preferred. Born from the Translational Genomics Research Institute (TGen), TD2 was formed in 2003 as a subsidiary of TGen, and less than two years later, opened its doors on the campus of the Mayo Clinic in Scottsdale, Ariz. In our 17 years of business, we have helped more than 600 biotech and pharma companies, maintaining hundreds of client studies per year. Among them, our team has been involved in more than 600 first-in-man major oncology medicines, including numerous trials that have led to approvals in both rare and large indications. TD2 is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, creed, disability, veteran's status, gender, sexual orientation, gender identity, or gender expression.

About the Company

TD2

INDUSTRY

Other/Not Classified

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