Sr. Clinical Research Specialist

5 days ago

Irvine, California, United States Infosoft, Inc. Full time

Job Title:
Sr. Clinical Research Specialist (Site Management)

Pay Rate:
$60 to $66/Hr

Duration:
12 months

Location:
Irvine, CA (Hybrid - Mon & Tue working onsite)

Our Client is a
Global medical device Manufacturer.

We are looking for
a Sr. Clinical Research Specialist (Site Management)
to
perform clinical site management
activities, including
reviewing informed consent forms (ICFs)
to ensure compliance with regulatory requirements, maintaining site essential documents in alignment with ALCOA+ standards, performing database quality checks to support data integrity, and communicating study progress and escalations. This position will also
support trial master file (TMF) preparation for PMDA submission
, prepare reports for Study Health meetings and Centralized Monitoring meetings, and support audit preparation activities.

  • Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge, and develop processes to mitigate recurrence throughout study phases
  • Conduct in-house and site
    (if applicable)
    reviews
    of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical
    Trial Master File (TMF)
    documents are compliant with Good Documentation Practices, our internal SOPs, and US and OUS regulations
  • Assess current processes, identify opportunities, and propose solutions to improve process efficiency within and across related functional areas
  • Partner with cross-functional teams (e.g., clinical data management, field teams) with query management, data reviews, and resolution

Requirements:

  • Experience managing up to 10 clinical sites at once (working on
    informed consent, IRB submissions
    , and other site duties)
  • Proficient in cleaning up, organizing, and
    managing trial master files
  • Work on
    PMDA or FDA submissions
  • Bachelor's Degree or equivalent in a related field
  • 5-7 years of experience required
  • Clinical background, familiar with the clinical study process, monitoring, GCP, and clinical study relevant regulations.
  • High compliance requirements and understanding that the rights and well-being of human subjects should be protected during clinical study.

Nice to have:

  • Previous monitoring experience within a cardiovascular setting

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