Clinical Research Regulatory Specialist I / II- Center for Clinical Research HYBRID

University Hospitals   Cleveland Heights, OH   Full-time
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Position Overview/Duties:

Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigators at University Hospitals Cleveland Medical Center.

  • Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal, external agencies or committees.
  • Coordinate and perform study specific regulatory processes across multiple complex studies of different therapeutic areas and phases including IND or IDE held investigator initiated trials.
  • Manage regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines and current regulations.
  • Embraces the principles and practice of leadership and professionalism in clinical research.
  • Provides mentorship and training on the clinical trial and regulatory process to staff members.

Position Overview/Duties:

Coordinate and manage the regulatory operations for clinical research studies conducted by principal investigators at University Hospitals Cleveland Medical Center.

  • Complete regulatory documentation required to conduct clinical research with the IRB, pharmaceutical sponsor, and other internal, external agencies or committees.
  • Coordinate and perform study specific regulatory processes across multiple complex studies of different therapeutic areas and phases including IND or IDE held investigator initiated trials.
  • Manage regulatory processes to maintain compliance with SOPs, GCP guidelines, sponsor guidelines and current regulations.
  • Embraces the principles and practice of leadership and professionalism in clinical research.
  • Provides mentorship and training on the clinical trial and regulatory process to staff members.

Qualifications: 

  • Bachelor Degree required. SoCRA (Society of Clinical Research Associates) , ACRP or RAPS preferred.
  • Requires two years of research experience. 
  • Detail oriented person with the ability to work independently on multiple tasks and manage time effectively. Ability to work consistently and effectively as part of a high performance work team.
  • Ability to understand and communicate regulatory requirements to others.
  • Demonstrate problem solving skills and effective negotiation skills.
  • Medical terminology preferred.
  • Strong written communication skills to write and edit documents with the ability to take scientific documentation and present to the general population. Excellent interpersonal and verbal communication skills.
  • Basic knowledge of computer operations and demonstrated computer skills in a variety of software environments required, ie Excel, Access, Word, database applications.

This job is no longer available.

University Hospitals

Cleveland Heights, OH