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Contract – Sample Management 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 Sample Management Associate (SMA) is responsible for providing administrative support to the clinical project to ensure that sample procurement and analysis is in accordance with the study protocol, Federal Regulations, Good Clinical Practice, ICH Guidelines, local regulations, and Standard Operating Procedures.

Here’s What You’ll Do:
  • Coordinate shipments of laboratory kits to investigational sites and/or third-party vendors;
  • Organize and assist in management of sample inventory: Ensure all study-related samples are collected, properly prepared, shipped, and stored according to requirements;
  • Work with clinical trial managers to forecast and update projections for laboratory supplies (e.g. lab kits);
  • Maintain trackers and present regular updates to team leaders;
  • Prepare agenda and meeting minutes for internal and external meetings or review and approve vendor meeting minutes, as required;
  • Assist with the development of the laboratory manual and the review of clinical documents such as Informed Consent and site training materials;
  • Manage laboratory start-up and implementation according to clinical trial timelines and production of sample tracking reports;
  • Participate in the sample reconciliation;
  • Attend Internal Study Team meetings and report on progress of assigned tasks;
  • Ensure study documentation is maintained per Trial Master File plans;
  • Travel as needed (i.e. to clinical sites) (approximately 20%);
  • Perform other day-to-day activities based on SOPs and GCP as assigned and/or required.
 
Requirements:
  • BA/BS with sciences major preferred and 0 – 2 years of research/research coordinator experience in academic or industry settings
  • Effective communication skills
  • Competent computer skills including Microsoft Office
  • Ability to effectively manage multiple timelines in a fast-paced work environment
  • Strong attention to detail and organizational skills
  • Solution-oriented
  • Knowledge of current GCP regulations and other applicable regulations preferred but not required
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