Sr. Clinical Trial Associate

Posted 12 days ago

summit therapeuticsMiami (FL)

Clinical Research Coordinators Research and Development in Biotechnology (except Nanobiotechnology)

SENIORITY

Senior

SALARY

$117,000 - $137,000

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About the role

Sr. Clinical Trial Associate

Location: ONSITE - Miami, FLOverview 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, with minimal oversight
Executes tasks as assigned by the Clinical Operations Manager, including study budget forecasting and tracking
Ensures accurate and timely documentation, including eTMF management, study contracts, and financial records in compliance with ICH-GCP, company policies, and regulatory requirements
Coordinates clinical operations activities across cross-functional teams, including contract management, vendor oversight, site start-up and activation, protocol deviation
Creates and maintains study-related materials, such as country and site binders and tracks trial milestones
Ensure the eTMF is being maintained up-to-date and all essential documents are appropriately filed in the eTMFCollaborates with CROs to ensure accurate data collection and entry into the CTMS and EDCAttends and contributes 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 Pay Transparency$117,000 - $137,000 USDActual 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. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

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