Clinical Trial Assistant (Hybrid or Remote)

Location

Hayward, CA | United States

Job description

Position Summary

Embark on a rewarding journey with our Clinical Operations team as a Clinical Trial Assistant (CTA), where you'll play an integral role in the seamless execution of clinical trials. As a CTA, your primary focus will be on efficiently managing day-to-day tasks related to clinical trial administration.

Responsibilities include coordinating and supporting the various aspects of clinical trials, overseeing interactions with vendors, and facilitating communication with clinical trial sites. Your attention to detail and organizational skills will be crucial in ensuring the smooth operation of in vitro diagnostics (IVDs) clinical studies and associated projects.

Responsibilities

• File, track, and maintain the Trial Master File (TMF)
• Prepare study-related materials for the training of internal and external staff
• Coordinate execution of Non-Disclosure and Confidentiality Agreements (NDAs) with study sites
• Review site-specific regulatory packets for completeness and accuracy
• Assist sites with study supplies management
• Prepare and distribute Investigator Site Files (ISFs)
• Track site payments and vendor invoices
• Conduct study closure activities (sites status, reconciliation activities, filing & archiving)
• Assist with meeting coordination, meeting materials, and meeting minutes
• Support quality review of electronic Case Report Forms (eCRFs)

Qualifications

• Education: Bachelor's degree (or higher) in a science or health-related discipline.
• Experience: A minimum of 1-2 years of relevant clinical development experience in a sponsor (Pharmaceutical or Biotech) or CRO role
• Clinical Trial Expertise: Demonstrated experience in clinical trial administration
• Regulatory Knowledge: Understanding of Good Clinical Practices (GCPs), International Conference on Harmonisation (ICH) guidelines
• Communication Skills: Exceptional written and verbal communication skills, with the ability to deliver clear instructions and guidance to teams within the organization and influence stakeholders at higher levels.
• Problem-Solving: Demonstrated problem-solving skills to address challenges effectively.
• Travel: Ability and willingness to travel to office Headquarters in intermittently

Our client acknowledges that equal opportunity for all persons is a fundamental human
value. Each employee and applicant will be considered on the basis of individual ability and merit, without regard to race, color, religion, age, sex, sexual orientation, gender identity, gender expression, pregnancy, national origin, marital status, physical disability, mental disability, medical condition, genetic information, protected military or veteran status, or any other characteristics.

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Job tags

Salary

$90k - $110k