Clinical Research Associate in Tampa, FL at Shriners Hospitals for Children

Date Posted: 10/24/2019

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    2900 North Rocky Point Drive
    Tampa, FL
  • Job Type:
  • Experience:
    At least 3 year(s)
  • Date Posted:
    10/24/2019

Job Description

The Clinical Research Associate is a specialized research professional working within the clinical research infrastructure. The Clinical Research Associate works directly with the Corporate Director Clinical Research supporting the oversight of Shriners Hospitals for Children (SHC) clinical research activities in accordance with the protocol, SHC’s policies and procedures, SHC’s hospital regulations, the Code of Federal Regulation, and Good Clinical Practice guidelines, when applicable. The person in this position also works with investigators and research staff at SHC sites educating, supporting, and facilitating appropriate and ethical clinical research activities. This ideal candidate’s primary responsibility is to help ensure proper study conduct and the timely generation and collection of quality data.

POSITION RESPONSIBILITIES:

Overall, works with the Corporate Director Clinical Research monitoring clinical research activities throughout Shriners Hospitals for Children to ensure research is being appropriately conducted, recorded and reported. This includes but is not limited to communicating with all SHC sites, conducting on-going education, developing policies and procedures, and the monitoring and auditing of clinical research activities.  

This position primarily works with the Clinical Research Program Manager and the SHC sites in implementing and maintaining the system wide use of the clinical research management system (OnCore), used to oversee and monitor clinical research activities. These activities would include but are not limited to process development, training, education, and access control.

Additionally, this position would work with the Clinical Research Program Manager in managing the daily operations of OnCore including but not limited to quality assurance testing, data entry, forms development, and data monitoring completeness, correctness and consistency.

Job Requirements

The qualified candidate will have experience in the following areas

  • 3 - 5 years relevant clinical research experience required
  • Experience in coordinating clinical research required
  • Experience with informed consents, IRBs, and federal regulations regarding clinical research compliance required
  • Experience working with large datasets, producing data queries, code mapping, and documentation required

  • Experience with collecting, analyzing, and publishing research data preferred

  • Experience in the coordination of intergroup or multi-site clinical studies preferred
  • Extensive experience auditing or monitoring, preferred

Minimum Education Required/Preferred:

  • Bachelor’s degree in a health care field, informatics, related clinical or scientific area, or equivalent experience, required
  • Master’s degree preferred
  • CCRP or CCRC certification preferred


Knowledge, Skills, and Competencies:

  • Maintains contemporary knowledge of clinical research regulatory requirements.

  • Extensive working knowledge of the clinical research process from protocol development to implementation including experience with clinical trials
  • Knowledge of, or ability to learn, the OnCore Clinical Trial Management System
  • Experience in the use of all modules of Micro Office, including Word, Excel, and Power Point.
  • Ability to function as part of an interdisciplinary team and interact with a variety of administrative and professional personnel
  • Ability to take a leadership role in implementing process development and changes, as needed
  • Ability to effectively communicate using oral and written skills
  • Ability to be detail oriented and the ability to ensure resolution and compliance
  • Ability to work independently using initiative and good judgment
  • Working knowledge of the applicable regulations related to product or agent being studied, the specific protocol, the informed consent process, and the sponsors’ policies and procedures
  • Working knowledge of Code of Federal Regulation related to Clinical Research
  • Working knowledge of ICH’s Good Clinical Practice Guidelines
  • Comprehensive knowledge of human subjects' protections methodology