Clinical Research Coordinator - Microbiologist

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Clinical Research Coordinator (GCP Role) Job Duties:

• Maintain a safe, fast-paced, and positive work environment.
• Draft study protocols, Informed Consent Forms, and other trial-supporting documents for IRB submissions of GCP-compliant studies.
• Obtain informed consent from human test subjects in a GCP setting.
• Involves sitting down with a subject for up to 1 hour and walking them through the Informed Consent documentation and answering any questions they may have regarding their participation in a Clinical Study.
• Obtain background health information from prospective study subjects to evaluate their eligibility to participate in Eurofins CRL, Inc. clinical trials.
• Obtain HIPAA Authorization from prospective study subjects.
• Interview prospective study subjects.
• Coordinate with Principal Investigator to ensure adequate subject recruitment has been met for each study.
• Interact directly with clients on an as-needed basis.
• Assist in training of other personnel as requested.
• Ensure safety and compliance with governmental regulations.
• Interact with FDA and clients as needed in the event of an inspection/audit.
• Follow all applicable Good Clinical Practice Regulations.
• Perform delegated duties assigned by Principal Investigator.
• Responsible for the technical conduct of assigned tasks.
• Make certain that all experimental data, including observations of unanticipated responses of the test microorganism are accurately recorded and verified.
• Follow all protocol and SOPs, reporting any deviations promptly to Principal Investigator.
• Note and inform Principal Investigator of any unforeseen circumstances that may affect the quality and integrity of the study when they occur.
• Prepare microbiological media and supplies.
• Assist with basic laboratory needs, such as cleaning, organization, or equipment validation.
• Maintain and regularly update resume and training records.
• Transfer all raw data, documentation, protocols, and final reports to the Archivist at the close of the study.
• Other duties as needed.

Qualifications

The ideal candidate would possess:

• Good time management skills.
• Clear communicators, able to give and receive direction clearly and efficiently.
• Adaptable, open to performing lab work when needed but also being restricted to clinical subject testing.
• Ability to be a self-starter and work cooperatively with others in a small-company environment.
• Ability to treat clinical study participants with respect and courtesy.
• Skill and familiarity with basic microbiology techniques (bacterial, fungal, and/or viral) in a BSL II environment 
• Excellent work ethic.
• Proficiency in Microsoft Office Suite software (e.g. Word, Excel)
• Experience in a clinical research environment and/or previous microbiology work experience 

Basic Minimum Qualifications:

• Reliable transportation and safe driving hi