About this role
SUMMARY
The CTA/Sr. Clinical Trial Associate supports the planning, execution, and oversight of clinical trials from study start-up through close-out. This individual plays a critical role in maintaining study documentation, tracking operational activities, and ensuring compliance with ICH-GCP, regulatory requirements, and internal SOPs. The CTA / Sr. CTA collaborates cross-functionally with internal teams, CROs, and clinical sites to ensure high-quality trial conduct.
RESPONSIBILITIES
Provide coordination, administrative support and tracking of trial activities to meet department and program goals. Support the set-up, maintenance and close-out of clinical trials
Assist with study start-up activities including vendor systems builds, regulatory document review, ethics/IRB queries, and site activation tracking
Maintain and QC Trial Master File (TMF), ensuring documents are filed accurately and on time
Support preparation and review of study documents (e.g., protocols, ICFs, study plans and Manuals etc.)
Track study metrics and site performance using CTMS and spreadsheets
Organize and attend internal and external study meetings; prepare agendas, generate meeting minutes, track action items and ensure team remains accountable to set deadlines
Work closely with CROs, vendors, and clinical sites to facilitate communication and resolve issues
Support oversight of monitoring visit reports and follow-up
Assist in creation and revisions of SOPs
EXPERIENCE & QUALIFICATIONS
Bachelor's degree in life sciences or a related field
2 years of experience as a CTA in sponsor or CRO setting.
Knowledge of ICH-GCP and general understanding of the drug development process
Experience working in clinical trial phases (I–3), global experience is a plus.
Experience working with eTMF systems (e.g., Veeva, Kivo, etc.)
Familiarity with CTMS and other clinical trial management tools
Experience working with CROs and other study related vendors
Strong organizational skills with high attention to detail
Excellent written and verbal communication skills
Ability to work independently in a fast-paced, deadline-driven environment
Comfortable collaborating in a cross-functional, global team
Ability to work on-site and adhere to an “office-first” culture is required.
The posted range reflects the current reasonable and good faith estimate of the base salary for this full-time position. Actual compensation will be based on a variety of factors including, but not limited to, relevant skills and experience, educational background and certifications, performance and qualifications, market demand for the role, geographic location and other organizational needs. This role also offers a competitive target bonus, equity, and a comprehensive benefits package.
We are committed to fair pay practices, and we regularly review our compensation programs to ensure they are competitive, equitable, and aligned with our values. Please note that the advertised pay range is not a guarantee or promise of a specific wage.
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