Clinical Trials Project Manager

Responsibilities

As our Project Manager (PM), you will function as a collaborator within a Clinical Trials
Laboratory Center which is sponsored by the Division of AIDS (DAIDS) / National
Institute of Allergy and Infectious Disease (NIAID) / National Institutes of
Health (NIH). You will play an
integral role in the implementation of clinical trials protocols, information
management and Network organization and structure.

In this role, you will be responsible for reviewing and
implementing protocol testing, reviewing laboratory quality assurance
information, working with laboratories to resolve audit/monitoring visit
findings and supporting capabilities required to conduct clinical trials as
required by the protocol Sponsor. You will also contribute to scientific technical aspects of clinical research laboratory
capacity building.

*Contract, may become career
Qualifications

Required:
  • 5
    or more years in laboratory/project management setting.
  • Knowledge in the following
    laboratory procedures and instruments:
    clinical chemistry, hematology, microbiology, virology, and immunology. The PM must have a thorough understanding of
    Good Laboratory Practices (GLP)/
  • Good Clinical Laboratory Practices (GCLP) and
    CLIA regulations.
  • Ability to recognize deviations from expected
    and/or normal results; analyze results for possible solutions;
    recommend new test methodologies and/or
    modify existing ones to achieve desired results; evaluate new laboratory
    techniques; prepare and analyze a
    variety of data; provide detailed
    documentation and analysis of clinical research data.
  • Ability to organize and direct the daily
    activities of participating laboratories; participate with supervisor in work
    planning, staff training, evaluating work, and counseling; evaluate quality
    control procedures; review work of others for conformance with quality control
    procedures; maintain quality control records; perform safety checks; ensure
    compliance with health and safety guidelines.
  • Ability to develop and provide instruction
    and training for staff at international laboratories in performance of
    laboratory procedures including total quality management.
  • Ability to develop necessary training tools
    to assist laboratories (i.e., checklists, training materials, etc.).
  • Working
    knowledge of assay validation, quality assurance and quality control procedures
    and properly documenting laboratory processes and procedures as well as
    corrective actions and preventative actions (CAPA).
  • Excellent
    interpersonal and client management skills with a professional and customer
    service oriented demeanor.
  • Excellent
    verbal and written communication skills, which may include business and
    technical writing, editing and proofreading.
  • Experience working with laboratory
    data/information management systems or laboratory database would be beneficial.

Preferred:
  • Bachelor's degree in science or health related field strongly preferred
  • Medical
    technologist degree or prior experience implementing clinical research testing
    is a plus.

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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