Lead Clinical Research Associate

Lead CRA - Oncology or Autoimmune

About the Opportunity:

The Lead Clinical Research Associate (LCRA) is responsible for managing the development, coordination and implementation of site management and clinical monitoring responsibilities for clinical studies with guidance from the Clinical Trial Manager. The LCRA provides expertise in clinical monitoring services for all phases of clinical studies.

Role and Responsibilities:

• Manages Regional Clinical Research Associates (CRAs)
• Onboarding and training on project-specific plans, study portals, and vendor operations.
• First line of contact for Regional CRAs for study specific issues and questions.
• Ensures all CRA monitoring is performed on time and per the monitoring plan.
• Reviews and approve monitoring trip reports (1st level review)
• Performs data review, query generation and query resolution.
• Supports the clinical team, especially the Clinical Trial Manager, in overseeing clinical monitoring and operational study execution
• Creates, maintains and reports metrics for monitoring study visit reports and study data.
• Assists 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 periodically conducts 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
• Assists in the review of required documents for Clinical Trial Material (CTM) release authorization.
• Participates in meetings and conference calls with internal project teams and external partners.
• Identifies deficiencies and coordinates 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)

Education, Experience and Qualification Requirements:

• Bachelor's degree
• Must have at least 5 years direct CRA field monitoring experience
• Must have at least 1-2 years’ experience managing CRAs.
• Excellent verbal, written communication skills and interpersonal and presentation skills are required.
• Microsoft Office (Outlook, Word, Excel and Power Point)
• 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 Date: ASAP
• 12 month contract
• California - remote with up to 20% travel
• W2 only