Clinical Research Associate

Location
94080, South San Francisco
Posted
Mar 29, 2018
Required Education
Bachelors Degree
Position Type
Full time

The Clinical Operations department at Calithera Biosciences is looking for an experienced Clinical Research Associate who will be involved in the day to day management of early phase clinical studies in oncology. We are looking for someone who has great communication skills and can function in this role fairly independently.

Duties and Responsibilities:

Support Clinical Operations site management activities including but not limited to:

  • Start-up activities: Investigational Package approval, Informed consent form review, sample reconciliation, document reconciliation
  • Support Clinical Operations vendor management activities, including but not limited to:
  • CRO staff training
  • Participate in CRO teleconferences
  • Sample management
  • Tracking of patient samples: PK, PDn, biomarker, biopsies, radiology scans and reports
  • Working with internal team and external vendors to ensure samples are analyzed, data transferred, and reports generated
  • Sample reconciliation with vendors and EDC
  • Management of laboratory vendors
  • Assist in Clinical data review activities- data listing review, protocol deviation review, trend review
  • Tracking enrollment
  • Participate in Site Initiations, Co-monitoring, and site close out activities
  • Assist in in review/creation of study plans
  • Assist in the quality control of clinical documentation
  • Assist in the development of other study-related documents
  • Review and assist in the revision of department SOPs
  • Collaborate with department members to identify Clinical Operations process, needs, and lessons learned

Qualifications and Requirements:

•   Bachelor’s degree or higher with a minimum of 2 years directly related experience

•   Experience with EDCs

•   Travel: 20%

Calithera Biosciences, Inc. is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status.

                                                                                                                                                                 

Interested candidates should submit their resume to hr@calithera.com