Sr. CRA - FSP Vaccine Job at ICON Strategic Solutions, Nebraska

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  • ICON Strategic Solutions
  • Nebraska

Job Description

Vaccine Clinical Research Associate

  • 3 to 5 protocols
  • 5 to 8 sites
  • 8 to 10 days on-site per month
  • Therapeutic areas: Vaccines trials.
  • Vaccine trials are fast-paced with quick database cleaning demands.
  • Requirements: Must have a four-year degree, completed all visits independently and have three years of independent monitoring. Open to any therapeutic experience.

What will you be doing?

As a Clinical Research Associate, you will monitor the progress of clinical studies at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.

  • Applies knowledge of ICONs policies and procedures
  • Demonstrates excellent written and oral communication
  • Demonstrates excellent knowledge of ICH/GCP
  • Displays ability to manage investigative sites to facilitate trial deliverables
  • Demonstrates ability to escalate issues appropriately
  • Conducts monitoring to confirm subject safety and data integrity
  • Describes and demonstrates the principals of IP accountability
  • Identifies scientific misconduct at the site level
  • Demonstrates working knowledge of Microsoft Office applications, Clinical Trial Management Systems, IVRS/IWRS and Electronic Data Capture platforms
  • Mentors CRAs new to the position or company
  • Serves as an observation visit leader
  • Conducts monitoring evaluation visits
  • Assists team lead in the development of trial tools or documents

You are:

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience required
  • Read, write and speak fluent English
  • 4 years of experience supporting clinical trials including 3 years of on-site monitoring experience (for CRA3/Sr. CRA)
  • Ability to travel for approximately 10 site visits each month
  • Proven success monitoring fast paced trials with quick turnaround times for database lock
  • High proficiency with Microsoft Office and company collaboration applications
  • Advanced skill in utilization of applicable clinical systems
  • Experience in monitoring all trial components (PSSV to COV) is preferred

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.

Job Tags

Work experience placement, Remote job,

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