Location: Austin, Texas, United States
Requisition Number: 2522
Position Title: Archivist, ATM Coordinator
Summary: Do you love science and making a difference and have a knack for organization? Worldwide Clinical Trials has a unique opportunity to join our South Austin bioanalytical lab as an Archivist. In this position, you will partner with Method Developers, Bioanalytical Study Managers, Analysts, and Instrument Operators to maintain up-to-date documents for use in regulated bioanalytical studies.
About Worldwide Clinical Trials, Early Phase: Nestled in the heart of South Austin, Worldwide’s Bioanalytical lab is a top-notch mid-size CRO that pushes boundaries, innovates, and invents — because the path to a cure for the worlds 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.
About You: You are a people-focused, analytical-minded individual with a passion for science and making a difference in the research industry. You will have experience setting up, organizing, and managing electronic files for bioanalytical research studies. You will really stand out if you have experience with TrackWise or a related EDC system.
Tasks may include but are not limited to:
- Process and archive all study-related raw data including correspondence files, reports, in support of bioanalytical and pharmacokinetic packages as applicable
- Support timely and efficient Retrieval of archived materials from off-site archival as requested
- Document & Manage in TrackWise (electronic system) Worldwide archived studies.
- Generate list of studies ready for electronic archival from Trackwise
- Maintain accurate inventory list for all studies stored on‑site
- Administrative responsibilities in support of equipment records and laboratory solution pages
- Administrative responsibilities around the issuance of controlled copies of Analytical Test Method for validation and sample analysis teams
- Prepare inventory list for studies that require electronic archival
- Final Formatting and issuance of Analytical Test Methods
- Knowledge of GLP and GCP regulations preferred
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
Skills & Abilities:
- Effective Communication Skills
- Excellent organizational skills
- Competent with Microsoft Word, Excel, and Adobe PDF
- High school diploma or equivalent
- Associates degree preferred
Employment Type: Regular
Community / Marketing Title: Archivest
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.