Clinical Research Regulatory Specialist - Peds Critical Care
University Hospitals - Cleveland, OH

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Our world-renowned health care network is anchored by our flagship facility, University Hospitals Case Medical Center. Located in Cleveland's historic University Circle, this 947-bed academic medical center and tertiary-care hospital is ranked by U.S. News and World Report as one of America's best hospitals in 13 medical and surgical specialties. It comprises three centers of excellence: Seidman Cancer Center, MacDonald Women's Hospital, and Rainbow Babies & Children's Hospital; and The Center for Clinical Research, the largest medical research center in Ohio.

Position Description/Essential Duties:
  • Coordinate and oversee clinical and regulatory operations in clinical research protocols conducted by principal investigator(s) at University Hospitals Case Medical Center.
  • Under limited supervision, manages and coordinates activities related to salary charges to grant awards in Oracle labor Distribution module, works as a Kronos Time keeper and serves as a key contributor to the grants accounting team in overall management of research grant awards
  • Organizes tasks and performs efficiently to meet management goals.
  • Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases.
  • Documents, records and assimilates accurate patient records and study records to ensure documentation compliance with sponsor guidelines and internal and external regulatory agencies

Position Requirements:

Two years of clinical research preferred OR an equivalent combination of relevant education and/or experience.

Ability to prioritize the work of multiple projects.

Education Requirements:

Bachelor’s degree or BSN.

Minimum of 2 years experience in clinical research or research certification such as Clinical Research Coordinator (CCRC), Clinical Research Associate (CCRA), or Clinical Research Professional (CRP)

Preferred Qualifications:

IRB experience, budgets and compliance experience.

IRIS experience preferred.

The preferred candidate will possess the following skills:
  • Detail-oriented with the ability to collect, compile, and analyze information.
  • Ability to understand and communicate research protocol requirements to others.
  • Able to work independently on multiple tasks and manage time effectively.
  • Proficiency with medical terminology.
  • Excellent verbal, written and communication skills.
  • Computer skills required - Excel, Access and Word.

** This is a Grant Funded Position **

University Hospitals is proud to be an equal opportunity employer

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