Clinical Trial Associate

Responsible for maintaining and managing a highly skilled, stable and functional in house monitoring team to meet the developing needs of the Global Oncology business and developing and rolling out new monitoring processes and work instructions to best implement consistency and efficiencies.

Responsibilities

  • Perform general administrative tasks to support team members with clinical trial execution, e.g., development and formatting of documents, review and reconciliation of study- specific information, etc.
  • Assist in maintaining study status updates on a weekly basis (e.g., IRB approvals, regulatory document collection, patient enrollment, monitoring status, etc.)
  • Track and prepare study-specific information using databases, spreadsheets, and other tools.
  • Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
  • Manage clinical and non-clinical supplies, including purchase and shipping.
  • Help with the development and distribution of site binders.
  • Set-up and coordinate meetings, take and distribute meeting minutes.
  • Support protocol and study-specific training with vendors, site personnel, and clinical sites.
  • Coordinating the movement of laboratory samples between clinical sites and central laboratories and tracking the status of samples and resulting laboratory data.
  • Ability to work with timelines and complete tasks according to deadline. Problem solving study-related issues; demonstrating resourcefulness and independence; escalation of issues as needed.
  • Should have knowledge and experience with Trial Master Files (TMF) and experience with electronic TMF systems (i.e. Veeva).
  • Will assist/back-up the Clinical Regulatory Operations Specialist for overall quality, maintenance, and completeness of Trial Master Files.
  • Other duties as assigned.

Qualifications 

  • Bachelor’s degree or equivalent curriculum (scientific or healthcare discipline preferred).
  • A minimum of 1 year of related experience is preferred, open to entry level candidates.
  • Knowledge in global regulatory and compliance requirements for clinical research.
  • Ability to work in a fast-paced environment with demonstrated ability to manage multiple competing tasks and demands.
  • Excellent communication and interpersonal skills are essential as the CTA interacts with many people of varying levels of responsibility for clinical trial programs.
  • Able to collaborate effectively with internal and external study management teams to meet project timelines.

 

Job Location: Cambridge, MA

Equal Opportunity Employer

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