Clinical Trial Associate
$117,000–$137,000 year
On-sitePalo Alto, California, United States
Job Summary
Manage study budgets, forecast costs, and track financial records while ensuring accurate documentation of contracts and eTMF compliance. Coordinate cross-functional activities including site start-up, vendor oversight, and protocol deviations, while collaborating with CROs to ensure data entry accuracy in CTMS and EDC. Draft meeting agendas and minutes, maintain study trackers, and create country and site binders to support clinical operations workflows. Participate in process improvement initiatives to enhance efficiency. Requires 4+ years of experience in clinical studies, proficiency in CTMS and eTMF, and knowledge of ICH-GCP and FDA regulations.
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) and 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
- Manage multiple tasks effectively and follow through on assigned tasks
- Ability to receive general instructions on new assignments and perform routine work independently
- Collaborate and work effectively within a team and within a multi-disciplinary environment
- Outstanding interpersonal skills coupled with the ability to communicate effectively in both oral and written form
- Attention to detail, accuracy and confidentiality
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