Regulatory Affairs Specialist - Clinical Research (Los Angeles)

  • Address:Los Angeles, CA 90001 (map)
  • Date Posted:08/30/16
  • Job Type:Full-time
  • Description:
  • Job Description Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).Works with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and approvals.Conducts or participates in the informed consent process including interactions with the HRPO (IRB) and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.Screens subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.Registers participants to the appropriate coordinating center (if multi-site study).Registers each participant in the billing matrix to ensure billing of study procedures to the appropriate funding source.Coordinates participant tests and procedures.Collects data as required by the protocol. Assures timely completion of Case Report Forms.Maintains study timelines.Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or WU Policy on Investigational Drug/Device Accountability.Completes study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.Retains all study records in accordance with sponsor requirements and University policies and procedures.Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.Assists PI in preparation of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.Works with the PI to manage the day to day activities of the study including problem solving, communication and protocol managementRequirementsBachelor’s degree in related field of science, health care or medicine OR APPLICABLE EXPERIENCE. Demonstrated clinical research experience, preferably in clinical oncology, including working knowledge of good clinical practices (GCP).ACRP certification within 3 years of employmentAbility to attend off- site meetings such as investigator meetings.English verbal and written skills to obtain and convey accurate information. SoCRA or ACRP certification preferred.
Ad ID: 45807861
  • Posted by: Ad Partner | View all ads
  • Profile: Active since 08/2016
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