job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A current top partnership with a research-driven biopharmaceutical company is known as a powerhouse that aims to develop treatments for difficult-to-cure diseases. This renowned employer has created 32 products, including Humira and Lupron, that have highly impacted lives across the globe. If you're looking to stand out in your field and lead the way to innovative therapies, this position is for you!
location: North Chicago, Illinois
job type: Contract
salary: $20.00 - 26.28 per hour
work hours: 9 to 5
- Member of the clinical team responsible for conducting Phase I-IV studies according to Federal Regulations and ICH guidelines. "Trial Master File Owner" responsible for managing and ensuring inspection readiness of clinical documentation / master files.
- Ensures real-time inspection readiness of clinical documentation / TMF by performing quality control (QC) of the TMF/artifacts to ensure completeness, document quality and timeliness of upload of artifacts to the TMF. Representative on study team(s) with ownership of the study Trial Master File (TMF).
- Develops and maintains study-specific TMF structure documentation.
- Provides TMF support for audits/inspections.
- Bachelors Degree required
- 1-3 Years' Experience Level.
- Prior research site experience as a Research Coordinator or Regulatory Coordinator
- Prior CRO experience as an in-house monitor
- Quality and Compliance in GCP
- Trial Master File experience
- Audit/ Inspection preparation (GCP)
- Prior experience as CRA
skills: ICH Regulations, TMF
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.