Clinical Research Associate Lead

5 days ago

Foster City, California, United States EPM Scientific Full time
Job Title: Lead Clinical Research Associate

About the Role:

The Lead Clinical Research Associate (LCRA) is a key member of our clinical team, responsible for managing the development, coordination, and implementation of site management and clinical monitoring responsibilities for clinical studies. The LCRA provides expertise in clinical monitoring services for all phases of clinical studies.

Key Responsibilities:

  • Manage Regional Clinical Research Associates (CRAs) and provide guidance on project-specific plans, study portals, and vendor operations.
  • First line of contact for Regional CRAs for study-specific issues and questions.
  • Ensure all CRA monitoring is performed on time and per the monitoring plan.
  • Review and approve monitoring trip reports (1st level review).
  • Perform data review, query generation, and query resolution.
  • Support the clinical team, especially the Clinical Trial Manager, in overseeing clinical monitoring and operational study execution.
  • Create, maintain, and report metrics for monitoring study visit reports and study data.
  • Assist in the design and development of study-related documents.
  • Assist in the review and tracking of regulatory documents and other study-related documents.
  • May need to conduct all types of site visits, including SQVs, IMVs, COVs, etc.
  • Responsible for the tracking of all study visits and reports and ensuring compliance with CMP.
  • Responsible for ensuring maintenance of site supply inventory and investigator site file maintenance.
  • Assist in the review of required documents for Clinical Trial Material (CTM) release authorization.
  • Participate in meetings and conference calls with internal project teams and external partners.
  • Identify deficiencies and coordinate training for CRAs.
  • May be responsible for the review and approval of time sheets and expense reports for CRAs.
  • Assist in the development and review of standard operating procedures (SOP).

Requirements:

  • Bachelor's degree.
  • At least 5 years of direct CRA field monitoring experience.
  • At least 1-2 years of experience managing CRAs.
  • Excellent verbal, written communication skills, and interpersonal and presentation skills are required.
  • Microsoft Office (Outlook, Word, Excel, and PowerPoint).
  • Experience with EDC, IRT, TMF, and CTMS.
  • Knowledge of FDA and/or EMEA Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials.

Contractual Details:

  • Up to 40 hours per week.
  • Start ASAP.
  • 12-month contract.
  • California - remote with up to 20% travel.
  • W2 only.

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