Job Description

• Assist Clinical Study Team Leads with preparation, review, handling, distribution, filing, and maintaining clinical research documentation according to standard operation procedures (SOPs).
• Assist Clinical Trial Master File Specialist in collecting, reviewing and uploading clinical study documentation prior to archival within the electronic Trial Master File (TMF) managed by TransPerfect in accordance with established SOPs.
• Conduct periodic review of study files for accuracy and completeness.
• 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, collection, 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.
• Perform 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:**

• 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
• Strong knowledge of FDA and GCP regulations as well as current ICH guidelines
• Strong computer, scientific, and organizational skills, including strong Microsoft Office 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
• Ability to communicate with Sponsor and CRO management

** 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
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• 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.