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Clinical Trial Managers and Sr. Clinical Research Associates

Nova Biomedical Denver ,CO
  • Posted: over a month ago
  • Temporary
  • Benefits: life_insurance, medical, vision, 401k, dental
Job Description

Nova Biomedical, a world leader in medical diagnostics and point of care technologies (POCT), is looking for experienced Clinical Trial Managers and Senior Clinical Research Associates for flexible temporary assignments with the potential to transition into part-time or full-time roles. We are seeking candidates located in Atlanta (GA), San Francisco (CA), San Diego (CA), Los Angeles (CA), Denver (CO), Seattle (WA), Idaho Falls (ID), San Antonio (TX), Columbus (OH), and Rochester (MN).

Primary responsibility is to monitor assigned clinical research site activities in accordance with FDA regulations, ICH GCP compliance, and company and study site SOPs.  More specific tasks will include:

  • Provide training to clinical Investigative Staff including site initiation visits, clinical protocol onboarding, and case report form completion with best practices
  • Monitor and assure that clinical trial protocol requirements are specifically adhered to, including accuracy of data collection/transcription and daily data transmittal
  • Verify operational integrity and quality control of the laboratory comparator and test methods during clinic sessions in partnership with the Investigative Staff
  • Provide clinical monitoring visit reports and ensure outstanding followup items are closed out in a timely manner
  • Identify potential protocol and/or product issues and report back to Investigative Staff and Sponsor for investigation and resolution
  • More experienced candidates, will have opportunity to assume role of the accountable owner for your clinical site, including building relationships, managing materials, and completing action items for followup

Qualifications:

  • Bachelor’s degree (or equivalent experience) in nursing, laboratory sciences, or similar is preferred
  • Significant experience monitoring clinical trials as a Clinical Trial Manager (CTM) or Clinical Research Associate (CRA), including experience with clinical trials of diabetes medical devices
  • Computer skills with proficiency in MS Office, including Word, Excel and PowerPoint
  • Clinical research certifications (ACRP, SoCRA clinical coordinator/CRA certification) are helpful
  • Excellent written/oral communication, presentation, and interpersonal skills. Ability to efficiently multitask
  • Problem solver, critical thinker, flexible and detailed oriented
  • Technical backgrounds, including familiarity with apps and device interrogation would be helpful in providing feedback to our engineering design teams, but not a required skillset for success in the role

Nova Biomedical will provide induction training and support. We are seeking candidates who are local to each study site, and therefore will not require air travel for the position. This is a temporary assignment with pay commensurate to experience and position. This assignment could lead to a long-term career growth and/or additional flexible work opportunities.

 

 

Company Description
Nova Biomedical develops, manufactures, and sells advanced technology blood testing analyzers based on electrochemical and optical measuring techniques. We employ over 1,000 people, have sales and service subsidiaries in seven countries, and have distributors in over 90 other countries. Nova has manufacturing facilities in Waltham and Billerica, Massachusetts, as well as Taipei, Taiwan.

Nova is one of the 25 largest in vitro diagnostic companies in the world and the largest privately owned in vitro diagnostic company in the United States.

Nova Biomedical

Why Work Here?

Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401

Nova Biomedical develops, manufactures, and sells advanced technology blood testing analyzers based on electrochemical and optical measuring techniques. We employ over 1,000 people, have sales and service subsidiaries in seven countries, and have distributors in over 90 other countries. Nova has manufacturing facilities in Waltham and Billerica, Massachusetts, as well as Taipei, Taiwan. Nova is one of the 25 largest in vitro diagnostic companies in the world and the largest privately owned in vitro diagnostic company in the United States.

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