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Contract - Clinical Trial Associate

Cambridge, MA
About Vedanta Biosciences, Inc.
 
Vedanta is pioneering the development of a new class of therapies based on defined bacterial consortia that act by modulating the human microbiome. Modulation of the human microbiota holds enormous promise to treat a broad range of immune and infectious diseases in ways that are completely different to existing drug classes. Breakthrough discoveries of our scientific team in the field of mucosal immunology have led to the first rationally designed drug candidates in the microbiome field.

We believe that in the near future, doctors will have an entirely new option to treat patients: bacterial consortia therapeutics. We are enabling this new drug class with groundbreaking and industry-leading scientific work powered by large-scale capabilities to identify, screen, and manufacture bacteria with drug-like properties. Our team is at the core of all we do - and we're excited to meet new team members!  
 
About Us, About You
 

At Vedanta, we value diversity in all its forms and are looking for candidates with a wide variety of perspectives, backgrounds, education, and experiences. We believe that a diverse and inclusive workforce builds the strongest team possible.

We're proud of our workplace culture. Our Vedanta Values inspire us to be the best professionals and colleagues possible. Our values are:
Respect - Collaboration - Execution - Effective Communication - Problem Solving - Scientific Thoroughness

The Role:
 
The Clinical Trial Associate (CTA) will be responsible for providing administrative support to the members of the clinical project team in order to facilitate management of studies.  The individual will perform study activities for assigned studies during the design, planning, preparation, execution, and close-out phases of the studies.  The CTA will prepare an agenda and document meeting minutes, generate and distribute status and laboratory sample reports as needed, and set-up and oversee the Trial Master File (TMF). The CTA will perform administrative tasks to support team members with study activities as needed
 
Here’s What You’ll Do:
  • Be responsible for set-up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files. 
  • Coordinate TMF transfer with CROs;
  • Assist with the auditing and reconciliation of all study-related documents for studies;
  • Work closely with the Study Team Leader and coordinate, tracks and manage logistics in support of studies;
  • Track study status, enrollment, regulatory documentation, laboratory samples, and site start-up status for assigned clinical projects;
  • Actively order and maintain ancillary clinical study supplies required for conduct of clinical studies;
  • Assist in planning, preparation, and distribution of materials for study meetings;
  • Prepare agenda and meeting minutes for internal and external meetings as requested;
  • Assist Study Team Leader with reporting of benchmark metrics to senior management;
  • Assist with the preparation of presentations and reports as required;
  • Assist with archiving of study documents for completed clinical studies;
  • Perform additional tasks as requested.
Requirements:
  • 2+ years of relevant hands-on study experience in clinical research, CRO or sponsor setting
  • Bachelor’s degree
  • Excellent communication (oral and written), organizational, and problem-solving skills
  • Excellent Microsoft Office skills
  • High energy individual able to effectively multi-task and strive in a dynamic start-up environment
  • Strong attention to detail
  • Strong knowledge of GCP guidelines and other regulatory requirements clinical trial management
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