As a Senior Clinical Trial Associate (Sr. CTA) you will be integral in supporting the Clinical Operations team throughout all stages of study activities. Your responsibilities will encompass site activation, patient recruitment, study monitoring, and managing relationships with sites and vendors during Phase 2/3 trials. You will work collaboratively with various departments, as well as with study sites, Contract Research Organizations (CROs), and other vendors.
This role will initially be offered as a contract position with the possibility of transitioning to a full-time role.
Key Responsibilities:
- Conduct site feasibility assessments and recruitment efforts, including reviewing Site Information Questionnaires.
- Ensure clinical documents (protocols, ICFs, manuals) are clear, accurate, and compliant with ICH/GCP guidelines.
- Review and oversee study plans, including Clinical Monitoring, Communication, Project Management, and electronic Trial Master File (eTMF) Management.
- Audit data fields within electronic data capture (EDC) systems and compile/download reports to aid in study management and data review.
- Participate in user acceptance testing (UAT) of clinical systems, such as EDC and interactive response technology (IRT), and may assist in authoring system requirements.
- Monitor and track essential regulatory documentation from clinical sites both before and during study conduct.
- Review site-specific Informed Consent Forms (ICFs).
- Assess Site Visit Reports for accuracy, quality, and consistency.
- Assist in managing study vendors.
- Support TMF quality control and address reconciliation findings.
Qualifications:
- Typically requires a minimum of 3 years of relevant experience or a combination of experience and education/training (e.g., Clinical Trials Design and Management Certificate).
Preferred Education:
- Bachelor's degree in biological sciences, health care management, or life sciences research; BSN/RN or experience in clinical trial management.
Preferred Experience:
- Solid understanding of the Trial Master File (TMF) structure, particularly the DIA model.
- Strong written and verbal communication skills with proven multitasking abilities.
- Effective time management and organizational skills.
- High attention to detail and accuracy.
Preferred Computer Skills:
- Proficiency in Microsoft Office (Word, Excel, Outlook), Smartsheet, electronic TMF, and other electronic clinical technologies.
Location:
This position is based in South San Francisco, CA, with an expectation of being in the office 3 days a week, Tuesday through Thursday. Remote applicants will not be considered at this time.