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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

• Assist Clinical Study Team Leads with preparation, review, handling, distribution, filing, and maintaining clinical documentation according to standard operation procedures (SOPs). Conduct periodic review of study files for accuracy and completeness.
• Assist Clinical Trial Master File Specialist in collecting, uploading and reviewing clinical study documentation prior to archival within the electronic Trial Master File (TMF) managed by TransPerfect in accordance with established SOPs.
• Assist Clinical Study Team Leads to manage documentation by carrying out tasks including but not limited to: ensure checklists and study plans are documented, approved, and filed; maintain GCP and 21 CFR standards; ensure accountability and accuracy of documentation; oversee and ensure electronic data integrity.
• Assist Clinical Study Team Leads with preparation, handling, distribution and destruction of clinical trial supplies and maintenance of tracking information for study product accountability.
• Assist Clinical Operations with the drafting, maintenance, and schedule of review of SOPs. Adhere to all approved client/vendor clinical research related SOPs and working practices.
• Assist with Quality Coordinator duties, to include the administration of QMS tasks including but not limited to: change control, document control, document edits, document drafting, and quality audits.

Demonstrate superior communication skills; attention to details; ability to think pro-actively and escalate concerns/ issues in a timely manner; comply with project or task timelines to support overall success in project milestones

Qualifications

The ideal candidate would possess:

• Strong knowledge of FDA and GCP regulations as well as current ICH guidelines
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) to effectively communicate with all stakeholders, and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Ability to think proactively and escalate concerns/issues in a timely manner
• Strong Microsoft Office skills
• Ability to communicate with Sponsor and CRO management
• Good project planning and management skills to ensure goals are met under tight timelines, as well as an ability to contribute creative and practical solutions to problems

Basic Minimum Qualifications:

• Bachelor's degree in biology, chemistry, or other related degree concentration
• 2+ years of experience in clinical trials in the pharmaceutical industry or medical device field
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

• Position is full-time, Monday-Friday, 8:00 am - 5:00 pm.
• Candidates currently living within a commutable distance of Richmond, VA are encouraged to apply
• 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
• #LI-EB1
• Authorization to work in the United States indefinitely without restriction or sponsorship

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.