Clinical Research Associate

Universal DX
Universal DX
United StatesPresencialCompetitivoPublicado hace 25 días
🇬🇧Inglés requeridoClinical operationsClinical ops
Universal DX

Clinical Research Associate

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About our Company:

Universal DX, Inc. is an international Company with a highly experienced team focused on cracking cancer's code. Through our multi-omics and bioinformatics models, we have figured out how to read the disease's signals in blood with high accuracy to detect cancer in its earliest stages. Starting with a colorectal cancer screening liquid biopsy test, we are building a multi-cancer platform that can identify the unique DNA regions associated with different types of cancers.

The Opportunity:

You will be part of a team that is passionate about developing novel diagnostic tests for the early detection of cancers. As part of the team, you will be in a Company that aims more than to become one of the leaders in the industry. We want to have a huge positive impact on society by achieving the ambitious purpose of "making cancer a curable disease by detecting it earlier".

How you'll contribute:

We are seeking an experienced CRA who has monitored clinical trials to ensure they comply with ICH/GCP guidelines, regulations, and study protocols.  They act as they key link between sponsors and site staff managing study site activities from site selection to close out ensuring data integrity, subject safety, and proper documentation.  The CRA is responsible for delivering high-quality clinical trial execution across assigned studies. The ideal candidate brings strong leadership, independent judgment, and the ability to proactively identify risks while ensuring compliance with ICH-GCP, regulatory requirements, and internal SOPs.

What you'll bring:

  • Conduct site qualification, initiation, routine monitoring, and close-out visits to ensure subject safety, data integrity, and protocol compliance.
  • Provide ongoing guidance and performance oversight to investigative sites; identify and escalate site or data issues.
  • Review, query, and reconcile clinical data; ensure timely resolution of outstanding issues.
  • Ensure site documentation meets regulatory and audit readiness standards.
  • Conduct site qualification, initiation, routine monitoring, and close-out visits to ensure subject safety, data integrity, and protocol compliance.
  • Provide ongoing guidance and performance oversight to investigative sites; identify and escalate site or data issues
  • Review, query, and reconcile clinical data; ensure timely resolution of outstanding issues.
  • Ensure site documentation meets regulatory and audit readiness standards.
  • Role requires 50-70% travel nationwide

Qualifications and Requirements:

  • 3+ years of clinical research experience, including independent on-site and remote monitoring.
  • Prior experience in a CRA role within a sponsor, biotech, or CRO environment.
  • Prefer Experience within Oncology
  • Bachelor's degree in life sciences, nursing, pharmacy, or related field (or equivalent experience).

Skills & Competencies:

  • Strong knowledge of ICH-GCP and regulatory requirements.
  • Excellent communication, presentation, and relationship-building skills.
  • Ability to work independently, manage multiple priorities, and adapt to fast-paced environments.
  • Strong analytical, problem-solving, and decision-making capabilities.
  • Proficiency in CTMS, EDC, eTMF, and common clinical systems.

 

What We´ll Offer:

  • 22 days of PTO with the possibility to carry over 10 days to the following year.
  • Company Holidays, plus your Birthday off! 
  • Company-sponsored benefit plans, including medical, dental, and vision insurance plus life, STD, and LTD coverage, and 401(k).
  • Flexible work schedule 
  • And more to come!

Why Now?

This is an exciting time to be at Universal DX. We are growing rapidly and starting our US operations by building up our team, starting our lab and business operations, and establishing strategic partnerships. 

We are looking for passionate changemakers to be a part of our journey in this expansive time for us.

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