Clinical Trials Associate

Clinical Operations South San Francisco, California


Description

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Clinical Trial Associate

 

Requisition ID:

 

Position Summary

 

The CTA will support the operational management and oversight of aspects of a clinical program.  The CTA will participate in the activities associated with the evaluation, initiation, management, and close-out of clinical trials within the Clinical Operations Department. The CTA role provides an outstanding opportunity to work in a cross-functional environment and collaborate with colleagues in Clinical Research, Biometrics, Regulatory & QA, and Program Management.   This individual will report into the Sr. Director of Clinical Operations. This is an in-house position.

 

Responsibilities

  • Assist in the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents. 
  • Clinical data review of data listings and summary tables, including query generation  
  • Assist in the oversight of CROs, third party vendors, and field CRAs  including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work; identify areas of concern and escalate to manager or CRO as appropriate
  • Support the review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work
  • Assist with CRA and third party vendor training on protocols and practices
  • Assist in identification and hiring of appropriate CROs and third party study vendors
  • Assist with meeting preparations such as investigator meetings, CRA trainings, etc.
  • Other duties as assigned

 

Qualifications

 

  • Previous clinical research experience preferable
  • Proficient with MS Word, Excel, Project and PowerPoint.  Experience with MS Access and MS Project a plus
  • Strong interpersonal, communication (written and verbal), and organizational skills
  • Demonstrated ability to work independently as well as part of a multi-functional study team
  • Attention to detail
  • Able to work effectively under a changing environment
  • Able to solve problems under pressure
  • Self-motivated and able to work effectively in a matrix/team environment 
  • At least 1 year of clinical operations work experience in the pharmaceutical industry or clinical research setting and working knowledge of GCP/ICH guidelines and the clinical development process.
  • Advanced MS Office skills a plus

 

 

Portola Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any characteristic protected by law.