Clinical Studies Specialist

Proclinical is currently recruiting for a Clinical Studies Specialist with a biopharmaceutical company located in North Chicago, IL. The Clinical Studies Specialist will be a member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines. This individual will act as the "Trial Master File Owner" responsible for managing and ensuring inspection readiness of clinical documentation and master files.

Job Responsibilities:

• Ensure inspection readiness of clinical documentation by performing quality control of the TMF and artifacts to ensure completeness, document quality and timeliness
• Representative on study team with ownership of the study Trial Master File
• Develop and maintain study specific TMF structure documentation and provides support for audits and inspections

Skills and Requirements:

• Bachelor's Degree required
• 2+ years of professional experience
• Prior Clinical experience is a plus
• Experience with TMF and/or other documentation systems
• Audit and/or inspection experience is a plus
• Tech savvy regarding clinical trial management systems
• Experience with Quality and/or Compliance
• Highly organized, strong written and oral communication skills

If you are having difficulty in applying or if you have any questions, please contact Amanda Rivera at 267-435-8555.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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