Clinical Trial Associate - Bayside Solutions : Job Details

Clinical Trial Associate

W2 Contract

Salary Range: $124,800 - $135,200 per year

Location: South San Francisco, CA - Hybrid Role

Job Summary:

As a Clinical Trial Associate, you will perform clinical administrative functions, including tracking clinical trials, maintaining study documents, providing logistical support to study execution teams (SET), and managing agendas and minutes. You will maintain the Trial Master File (TMF), ensure audit readiness, assist with study-related documents and tools, and support study closure activities in compliance with SOPs and Good Clinical Practices standards.

Duties and Responsibilities:

• Perform general clinical administrative functions such as clinical trial tracking and logistical support to the study execution teams (SET), including generating and distributing SET meeting agendas and minutes.
• Track and maintain study information and report on study progress and enrollment.
• Track and maintain study-related documents, including essential regulatory documents from clinical sites and any other supplementary documentation as appropriate (CVs, FDA 1572s, etc.)
• Independently maintain the study Trial Master File (TMF) following relevant SOPs to ensure accuracy, completeness, and adherence to the SOPs requirements.
• Maintain and ensure that all documentation is audit-ready.
• Assist in reviewing and developing study-related documents and tools, including site regulatory packages, study manuals, reference documents, and instructions.
• Assist with study closure activities such as ensuring final site payments, reconciliation activities, filing, and archiving all study documents.
• Assist with tracking study budgets and vendor invoices to ensure timely approval and payment.
• Assist with vendor management and associated logistics, as assigned.
• Assist with clinical data review, informed consent development and review, and creating and implementing departmental procedures.
• Perform all responsibilities following SOPs, established guidelines and work instructions, and appropriate industry and GCP standards.
• Contribute to broader organizational goals and activities as assigned.
• Maintain accurate and timely work time recording by clocking in and out using designated timekeeping systems. Adhere to company timekeeping policies, including rules regarding overtime, meal breaks, and reporting procedures for any discrepancies.

Requirements and Qualifications:

• BS/BA in Life Sciences or related discipline
• 3+ of related experience or education and training
• Knowledge and understanding of FDA and ICH Guidelines, Good Clinical Practices (GCP), medical terminology, and clinical trials
• Highly proficient in software applications such as Word, Excel, and PowerPoint
• Good written and verbal communication skills and ability to multitask
• Efficient time management and organizational skills
• Strong interpersonal and collaboration skills
• Strong attention to detail and accuracy in work

Desired Skills and Experience

Clinical trial, FDA Guidelines, ICH Guidelines, GCP, SOP, Trial Master File, vendor management, clinical data, Word, Excel, PowerPoint

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as a W2 candidate.

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