长沙招聘

- Assist in performing / perform contracted and non-contracted compliance audits including, but not limited to: file audits, site audits, data audits, document audits, and process assessment activities.

- Assist in communicating / communicate findings verbally and in writing to internal and external project team(s).

- Ensure appropriate corrective actions on noted observations of audits conducted.

- Become thoroughly familiar with all company SOPs.

- Serve as a consultant to company personnel on the interpretation of SOPs, ICH GCP Guideline, and applicable regulations.

- Participate in CRO assessments and/or audits by sponsor companies, and regulatory inspections.

- Participate in the quality control review process of CQA deliverables.

Established in 1985, Theorem Clinical Research is one of the industry’s leading full-service, global CROs. Theorem provides core CRO services for Phases I to IV, but with niche business units in the areas of Technical Services, Medical Device and Pharmaceutics.

So what makes us different? Theorem can manage even the most complex project--from study design to product launch and beyond. Our clients see us as “the right size” CRO—big enough to successfully manage your large global trials, but with a personalized service level you might associate with a smaller organization. And we execute with speed, flexibility and an attention to detail that drives high-quality performance. Additionally, we have unique strengths in Asia Pacific and Latin America.
Our comprehensive clinical service offering includes the following:

?    Project Management
?    Clinical Monitoring*
?    Clinical Data Management*
?    Regulatory Affairs*
?    Clinical Quality Assurance
?    Safety Surveillance/Pharmacovigilance*
?    Biometrics*
?    Clinical Writing
?    Investigator Agreements
?    Medical Affairs
?    Patient Recruitment

The Theorem Clinical Research name is new. But it is built on a long history of delivering exceptional services and support for all phases of clinical research. Before launching in 2011, Theorem Clinical Research operated for nearly two decades as Omnicare Clinical Research under the Omnicare, Inc. parent company. Dating back to the late 1990s, Omnicare Inc. acquired several smaller CROs—including Coromed and IBAH—and launched Omnicare Clinical Research in the year 2000.

Today, we have grown into a global organization with 900+ employees located throughout 27 countries. As our story continues to unfold, one factor remains constant: our people are committed to our clients and their success. For that reason, we strive to enhance our business on an ongoing basis. Whether it’s by opening a new office location, implementing a new technology, or maximizing a strategic new partnership, Theorem Clinical Research understands how to meet your evolving drug development needs.