Clinical Research Assistant

Description

• Keep regulatory files up to date (training records, financial disclosures, FDA forms, CVs, licenses, etc.).
• Monitor study payments and generate invoices to ensure adequate funding throughout the trial.
• Collaborate with internal and external investigators and participating centers in multi-center studies.
• Perform administrative duties as assigned in a timely manner.
• Maintain accurate and complete regulatory documentation, including consent forms, case report forms, SAE reports, and source documents, in compliance with IRB, FDA, OHRP, HIPAA, and other agency guidelines.
• Submit internal documentation for contract execution and maintain communication with contracting officers and sponsors during budgeting and negotiation.
• Organize site feasibility and initiation visits, including completion of feasibility questionnaires.
• Participate in weekly research staff meetings.
• Prepare and submit research protocols, consent forms, recruitment materials, and IRB applications for human subjects’ approval.
• Complete IRB paperwork and submit internal and external Serious Adverse Events (SAEs) and IND Safety Reports as required.
• Assist with coordination and preparation for institutional, pharmaceutical, and internal audits.
• Provide facility tours for sponsors, CROs, and other research-related visitors.
• Develop research project budgets based on protocol requirements and published research costs, ensuring consistency across protocol, budget, and informed consent documents.
• Ensure timely filing of annual renewals and amendment submissions to the IRB.
• Protect the rights and confidentiality of research participants, ensuring proper consent and HIPAA compliance.

Requirements

• Education: High School Diploma or GED required.
• Experience: Minimum of 1 year of clinical research-related experience required.

Benefits

• Employee Assistance Program
• Medical, dental & vision
• Transportation benefits
• Health Spending Account (HSA)
• Short and long-term disability
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Critical Illness, Accident, and Hospital
• Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Los Angeles,CA. Application Deadline This position is anticipated to close on Dec 31, 2025.
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)

Training + Development

Interview process

Visa Sponsorship

Security clearance