Document Coordinator, Scientific Associate
Location: Austin, Texas, United States
Requisition Number: 2838
Position Title: Scientific Associate, Document Coordinator
The Scientific Associate, Document Coordinator with direct supervision is responsible for the QC reviewing or generation of final reports and Analytical Test Methods (ATMs) for studies conducted at Worldwide Clinical Trials. The individual should have experience and working knowledge in reviewing scientific and regulatory reports and the ability to meet regulatory and Sponsor requirements. This individual performs routine work with general oversight and meets timelines.
Tasks may include but are not limited to:
- Review or compile study reports for accuracy and compliance with Worldwide’s SOPs, client guidelines and current regulatory guidances; Review and update controlled forms such as SOPs, Analytical Test Methods and deviations
- Reading source documentation (bioanalytical, validation, amendments, SOPs, or ATMs) and understanding proper approach for compilation or reviewing of final report
- Verifying all materials and information needed to compile or review the report are provided and promptly notifying document requester about need for additional information, material or clarification
- Efficiently using computer software (such as MS Word, MS Excel, Adobe Acrobat XI Professional, CoreDossier, Extedo, Watson, and NuGenesis) to compile, review and revise reports and other documents
- Compile data and documents for reports, enter and update ATM information into laboratory databases; Enter information from study proposals into database for clinic and laboratory use, uploading documents as needed to FTP sites in accordance with Worldwide SOPs, Creating and maintaining proper network directory structure for the storage and archival of document files
- Following all applicable safety guidelines
OTHER SKILLS AND ABILITIES:
- Advanced computer skills, including working knowledge of Microsoft Office products
- Familiarity with the corporate policies, goals, and objectives; normally acquired after three months of on-the-job exposure to Worldwide operations
- Knowledge of GLP regulations acquired through on-the-job training and experience
- Ability to coordinate multiple projects and have the flexibility needed to adjust to changing priorities and unforeseen events
- Ability to interact professionally and to work independently or in teams with excellent oral and written skills
- Ability to prioritize work and define steps needed to achieve assigned project goals; Ability to use logical inferences to understand the “big picture” and long-term implications of these issues.
- Bachelor’s degree, with a scientific focus, and 0 -2 years of relevant work experience required.
- Experience in editing, regulatory affairs, clinical research, science, or other relevant area preferred
Employment Type: Regular
Community / Marketing Title: Document Coordinator, Scientific Associate
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide Clinical Trials is an equal opportunity employer, dedicated to a policy of non-discrimination in employment on any basis including age, sex, color, race, creed, national origin, religion, marital status, sexual orientation, political belief or disability.