Senior Clinical Trial Project Manager

Full Time
Los Angeles, CA 90095
Posted
Job description
Responsibilities

Reporting to the Director and Administrative Director of the Parker Institute for Cancer Immunotherapy (PICI) Center at UCLA, the Clinical Trial Senior Project Manager will be responsible for the organization and conduct of the daily activities of the PICI Center, in particular ensuring that all PICI Center studies protocol procedures have been completed accurately, safely, and in a timely manner. Duties include; but are not limited to:
  • Supervision of research staff, students, and volunteers
  • Regulatory coordination of the PICI Center trials, including orchestrating accurate documentation and communications within UCLA’s institutional governing boards and federal or state regulatory bodies and funding agencies.
  • Responsible for preparation of studies, drug accountability and review
In this role, you will coordinate communication with PICI offices and other centers, meeting organization, progress reports, and requests for applications and funding, and ensure that clinical studies are conducted according to applicable federal and state regulations, and Cancer Center guidelines. You are also responsible for research assessment and patient intervention under the supervision of the Principal Investigator and completion of the Project Manager’s study related procedures. You will participate in patient recruitment and enrollment, quality assurance, protocol dissemination to health care professionals, patients and family members, data management (form build/management, data entry and data audit/review process), biospecimen management, and relevant departmental and divisional SOPs.
Qualifications

Required:
  • Experience in submitting Investigational New Drug as well as communicating with FDA during submissions
  • Experience in central IRB management.
  • Working knowledge of “Good Clinical Practices,” as defined by the FDA.
  • Demonstrated understanding of confidential information (Protected Health Information).
  • Strong knowledge of Federal Regulations, including Device, GCP and ICH and the ability to apply knowledge to early development, feasibility and clinical study setting
  • Demonstrated English writing skills to generate original correspondence, including reports, using correct grammar, syntax, and punctuation.
  • Skills in performing duties with frequent interruptions and/or distractions.
  • Willingness to travel between UCLA Westwood and Santa Monica Clinic.
Preferred:
  • Demonstrated working knowledge of current medical terminology specific to oncology, to accurately read entries in patient charts, and record accurate and timely information into study records and other appropriate research data forms.
  • Demonstrated experience working with Electronic Medical Record (EMR) systems such as Epic, Cerner, etc.

UCLA is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected Veteran status.

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