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Senior Clinical Trial Associate

  • Permanent
  • Anywhere

Website Corbus Pharmaceuticals

Corbus Pharmaceuticals

Company : Corbus Pharmaceuticals

Country: United States

Location : Park Place Industrial Park, Massachusetts

Post: Fri, 10 Sep 2021 04:59:38 GMT

Expires: Sun, 10 Oct 2021 23:59:59 GMT

Apply Job : Apply Online

—————————— Job Description ——————————

Job Description

The Senior CTA is a highly-skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and helping lead the study team across all investigator sites. Based on experience, the Sr. CTA assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the Sr. CTA independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The Senior CTA may act as a team lead or mentor and/or train more junior team members.

PRIMARY RESPONSIBILITIES:

* Ensure compliance with protocol and overall objectives across all investigator sites
* Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
* Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
* Execute study activities according to study protocol, regulatory guidelines and operational plan
* Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
* Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
* Participate in study start-up, conduct and closeout activities
* Assist preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
* Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
* Assemble and distribute regulatory binders to clinical sites
* Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
* Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers.
* Assist with preparation and distribution of investigator site contracts and budgets
* Maintain the Trial Master File for all clinical projects

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