Lead Clinical Trial Specialist

2 weeks ago

Norwood, Massachusetts, United States Corbus Pharmaceuticals Full time
Job Overview

Company Overview:

At Corbus Pharmaceuticals, we are driven by our mission to innovate and improve patient outcomes through precision oncology. Our diverse team thrives on collaboration and creativity, fostering an environment where unique talents can shine.

Position Summary:

The Senior Clinical Trial Associate (CTA) plays a crucial role in the execution and management of clinical studies. This position involves guiding the study team across various investigator sites, ensuring that all activities align with regulatory standards and project objectives. The Senior CTA is expected to handle complex tasks with a high degree of independence, utilizing problem-solving skills to address challenges as they arise.

Key Responsibilities:

  • Oversee compliance with study protocols and objectives across all participating sites.
  • Manage project-related tasks from initiation to database lock, ensuring adherence to protocols and regulatory guidelines.
  • Collaborate with various departments and external partners to maintain high-quality study outcomes.
  • Implement study activities in accordance with regulatory requirements and operational plans.
  • Review critical study documents, including protocols and consent forms, to ensure comprehensive understanding of the study drug and procedures.
  • Stay informed on SOPs, Good Clinical Practice (GCP), ICH guidelines, and relevant legal and ethical standards.
  • Engage in study start-up, execution, and closeout processes.
  • Assist in vendor proposal preparations and track submissions of contracts and agreements.
  • Collect and verify site regulatory documents for accuracy and completeness.
  • Prepare and distribute regulatory binders to clinical sites.
  • Draft and assist in the creation of trial-related documentation and tools.
  • Support project management tasks, including maintaining meeting records and tracking study progress.
  • Help prepare and manage investigator site contracts and budgets.
  • Maintain the Trial Master File for all clinical projects.

Qualifications:

  • Bachelor's Degree in a health sciences-related field, RN, or equivalent discipline.
  • 3-5 years of relevant experience in clinical trials.
  • Exceptional written and verbal communication abilities.
  • Proficient in Microsoft Office Suite (Word, Excel, Project).
  • Strong analytical and problem-solving capabilities.
  • Demonstrated attention to detail and ability to work with urgency.
  • Familiarity with Electronic Data Capture (EDC) systems and Clinical Trial Management Systems (CTMS) is preferred.
  • Experience with Veeva is a plus.
  • Outstanding organizational and time management skills.

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