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Date Added: Wed 09/06/2021

Clinical Research Associate

San Francisco, CA, US
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Company: BAYSIDE SOLUTIONS

Job Type: Permanent, FullTime

Job Description

 

What you will do: (Responsibilities)

The Clinical Research Associate (CRA) supports moderately complex clinical trial activities in support of the clinical trial team to ensure successful clinical trial execution. The CRS works closely with the Clinical Trial Manager to ensure site related start-up through close-out activities are conducted in accordance with good clinical practice, regulatory requirements, and relevant SOP' s. The CRA may assist with vendor oversight and management. They will identify issues in a timely manner and escalates to management as appropriate. The CRA may complete monitoring visit report review and perform co-monitoring to verify that the rights and well-being of human subjects are protected; that the reported trial data are accurate, complete, and verifiable from source documents; that the conduct of the clinical trial is in adherence to protocol, GCP/ICH, and SOPs. The CRA will ensure site enrollment metrics are closely tracked to identify risk and elevate as appropriate to support enrollment goals.   The CRA will also oversee the receipt, approval, filing, and tracking of essential documents for the duration of the study.

 

Minimal Qualifications:
  • BA/BS/BSN in related life sciences field with prior experience with clinical research. Advanced degree preferred
  • 2+ years in the role of Clinical Research Associate in pharmaceutical/drug development, with a preference for oncology or immunotherapy/cellular therapy experience 
  • Experience in the preparation, monitoring, and execution of clinical studies is a plus
  • Ability to motivate clinical site personnel to maintain/accelerate timelines in order to achieve clinical operational milestones
  • Some understanding of medical/therapeutic area knowledge and medical terminology is a plus
  • Able to comply with safety standards and respect privacy and confidentiality
  • Superb verbal and written communication skills
  • Excellent organizational skills along with strong attention to detail
  • Track record of working successfully in a cross-functional team 
  • Willingness and capability to work effectively in a smaller pharma company (i.e. willing to roll-up your sleeves as necessary to help get the job done)
  • Demonstrated ability to handle a high volume of highly complex tasks within a given timeline
  • Full training in Good Clinical Practice (GCP) guidelines and thorough knowledge of FDA regulations
  • Strong verbal and written communication skills
  • Willingness to travel domestically and internationally  

 

Preferred Qualifications: 

·        3+ years' experience in the role of Clinical Research Associate Preferred  Prior experience in immuno-oncology, personalized medicine, T cell therapy a plus 

·        Prior experience in a hands-on early development role building out a department within a small organization a plus

 

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