Tara Ohrazda, CCRP

Experience

• 

  Mercy Health Partners

  Jan 1998 - Jan 2000

  Compensation Analyst
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  AT&T

  Jan 2000 - Jan 2004

  • Assistant Staff Manager

    Jan 2001 - Jan 2004

  • Field Service Manager

    Jan 2000 - Jan 2001
• 

  Light Sciences Oncology

  Jan 2005 - Jan 2011

  Project Manager for Phase 3 IND trials in metastatic colorectal cancer and hepatocellular carcinoma across Europe and Asia. Responsible for coordination of multiple operations, clinical research, data management and imaging vendors from study start-up through project close-out. Successfully completed enrollment, two interim analyses and database lock for primary analysis within projected timeline and budget. Oversaw clinical department operations including budget negotiations and management, contract review, vendor selection and management, and clinical trial insurance policies. Managed study progress by tracking regulatory submissions and approvals, recruitment and enrollment, case report form submission and completion, data query generation and resolution. Provided oversight and support of project management team to ensure compliance with SOPs and ICH/GCP guidelines. Clinical operations support to Chief Scientific Officer, Chief Medical Officer and VP of Clinical Development. Acted as pivotal point of contact for the clinical trial team and contract organizations. Established trial master file structures and maintained all essential documents for Phase 1 - 3 studies. Completed document review of ongoing studies to maintain regulatory compliance and was primary coordinator for regulatory submissions.

  • Clinical Operations Manager

    Jan 2009 - Jan 2011

  • Associate Clinical Operations Manager

    Jan 2008 - Jan 2009

  • Executive Assistant/Clinical Trial Assistant

    Jan 2005 - Jan 2008
• 

  Fred Hutch

  Jul 2012 - now

  Administer sponsored research program encompassing over $7M annually from federal and industry funding sources. Facilitate grant and contract applications, negotiate budgets, monitor expenditures, manage multi-site subaward agreements and associated annual reporting to sponsoring agencies. Manage complex federally funded program project award and cooperative group awards supporting the national chronic GVHD consortium across 15 participating investigative sites and 4 clinical protocols. Liaise with clinical sites of practice and investigative teams to plan study logistics within the clinical setting. Study experience includes Phase 1 - 3, compassionate use and data/specimen collection studies. Show less

  • Program Operations Director, Clinical Transplant Research

    Jul 2022 - now

  • Research Administration Manager, Clinical Transplant Research

    Jul 2012 - Jun 2022