SENIOR CLINICAL TRIAL ASSOCIATE Overview of Role: The Senior Clinical Trial Associate (Senior CTA) is an experienced clinical operations professional who is responsible for supporting the daily workflow of clinical operations activities. They will provide robust administrative support to study teams throughout the study. Key administrative activities include, but are not limited to, managing meeting invitations, creating agendas and meeting minutes, study document filing, maintaining study trackers, and oversight of the eTMF and vendors.
Role and Responsibilities: - Provides comprehensive administrative support to the clinical operations study team,including managing meeting logistics, creating agendas, and drafting meeting minutes, withminimal oversite
- Executes tasks as assigned by the Clinical Operations Manager, including study budgetforecasting and tracking
- Ensures accurate and timely documentation, including eTMF management, study contractsand financial records in compliance with ICH-GCP, company policies and regulatoryrequirements
- Coordinates clinical operations activities across cross-functional teams, including contractmanagement, vendor oversight, site start-up and activation, protocol deviation
- Creates and maintains study-related materials, such as country and site binders and trackstrial milestones
- Ensure the eTMF is being maintained up-to-date and all essential documents areappropriately filed in the eTMF
- Collaborates with CROs to ensure accurate data collection and entry into the CTMS andEDC
- Attend and contribute to team meetings, taking detailed meeting minutes
- Supports clinical study management as delegated by Clinical Operations managers, including liaison with external vendors
- Actively participates in process improvement initiatives to enhance clinical operations efficiency
- All other duties as assigned
Experience, Education and Specialized Knowledge and Skills: - Bachelor's degree in biological sciences, health sciences or medical field, or equivalent combination of education and experience required 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) required • 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
This is the pay for this position
Pay Transparency
$117,000-$137,000 USD
Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
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