Clinical Trial Associate

Summit Therapeutics•Princeton, NJ

4h•$117,000 - $137,000

About The Position

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.

Requirements

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.

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 eTMF.
Collaborates with CROs to ensure accurate data collection and entry into the CTMS and EDC.
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.