Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.
- Applies GMP/GLP in all areas of responsibility, as appropriate
- Drafts protocols, sample analysis outlines (SAOs), amendments and study scheduling, as appropriate, using proposal outline or client-supplied information.
- Reviews study compliance against protocol, standard operating procedures (SOPs), and regulatory agency guidelines.
- Communicates and interacts with various departments within, as well as, working in collaboration with clients.
- Updates and maintains project tracking systems, as appropriate.
- Responsible for report preparation, including table and figure preparation. Compiles analytical information from laboratory groups.
- Participates in and assists Study Director/Principal Investigator (SD/PI) with pre-initiation and other study related meetings, as required.
- Maintains well-documented, organized and up-to-date study folders/files including study schedules, protocol/report, and correspondence.
- 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 the specified time lines.
- Reviews client comments and makes decisions, including appropriate study personnel as necessary, to ensure that all relevant report/raw data clarifications are completed.
- Responsible for report productions through finalization, including archival of data as appropriate.
- Assists with routine client visits, as requested.
- Manages data transfer to clients, as requested.
- Assists SD/PI in monitoring study phases.
- Performs other duties as assigned
- Bachelor degree in science or related experience. Relevant experience may be substituted for education.
- Excellent communication, presentation and interpersonal skills.
- Excellent interpersonal skills, as well as, service skills (internal and external) including attention to detail, accuracy, confidentiality and communication skills.
- Knowledge of grammar, punctuation, composition, and spelling according to company standard conventions.
- Efficient use of word processing software, database, spreadsheet, and specialized software programs.
- Knowledge of a variety of studies in the department and client base.
- Knowledge of regulatory agency guidelines.
- Authorization to work in the United States indefinitely without restriction or sponsorship
Position is Full-Time, Monday-Friday, first shift,
withadditional hours, as needed.Candidates currently living in a commutable distance to Indianapolis, IN are encourage to apply.
What we Offer:
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
This job has expired.
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays