Sr. Clinical Trial Associate
$117,000–$137,000 year
On-siteMiami, Florida, United States
Job Summary
Manage clinical operations administrative workflows by coordinating meeting logistics, drafting agendas and minutes, and overseeing eTMF maintenance. Execute assigned tasks including study budget forecasting, tracking, and ensuring accurate documentation of contracts and financial records per ICH-GCP guidelines. Coordinate cross-functional activities such as vendor oversight, site activation, and protocol deviations while collaborating with CROs for data entry into CTMS and EDC. Maintain up-to-date trial milestones and country/site binders to support study management. Requires 4+ years of clinical study experience and proficiency with CTMS and eTMF systems.
Required Qualifications
- Bachelor's degree in biological sciences, health sciences or medical field, or equivalent combination of education and experience
- 4+ years of experience in clinical study environment within CRO or Pharmaceutical company
- Experience using Clinical Trial Management Systems (CTMS)
- Experience using Clinical Trial Master File Systems (eTMF)
- Strong understanding of the phases of clinical drug development and clinical operation processes from start-up to close-out
- Knowledge of applicable FDA Code of Federal Regulations, Good Clinical Practices, and ICH guidelines
- Ability to organize, prioritize tasks, identify and resolve issues efficiently
- Ability to receive general instructions on new assignments and perform routine work independently
- Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form
- Attention to detail, accuracy and confidentiality
- Location: ONSITE - Miami, FL
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