Clinical Research Regulatory Specialist I Peds Hematology - Grant Funded

University Hospitals   Chardon, OH   Full-time
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Position Summary/Essential Duties:

1.         Comprehends knowledge of scientific concepts related to the design and analysis of clinical trials; how drugs, devices and biologicals are developed and regulated.

2.         Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study. 

3.         Encompasses study management and GCP compliance; safety management (adverse event reporting) and handling of investigational product.

4.         Facilitates all elements of communication within the site and between the site and sponsor, CRO and regulators; understands teamwork skills critical to responsible conduct of clinical research.

5.         Embraces the principles and practice of leadership and professionalism in clinical research.


Position Summary/Essential Duties:

1.         Comprehends knowledge of scientific concepts related to the design and analysis of clinical trials; how drugs, devices and biologicals are developed and regulated.

2.         Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study. 

3.         Encompasses study management and GCP compliance; safety management (adverse event reporting) and handling of investigational product.

4.         Facilitates all elements of communication within the site and between the site and sponsor, CRO and regulators; understands teamwork skills critical to responsible conduct of clinical research.

5.         Embraces the principles and practice of leadership and professionalism in clinical research.


Education.

Completion of a bachelor's degree and some related experience OR associate’s degree with 4 years of clinical and/or research experience required..

 

Required Credentials, License, and / or Certifications.

N/A

 

 

Experience & Knowledge:

Ability to prioritize the work of multiple projects. 

 

 

Special Skills & Equipment Knowledge:

Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively.  Write and edit technical documents.  Ability to understand and communicate regulatory requirements to others. Medical terminology.  Excellent verbal, written, interpersonal skills.

 

 

This role encounters Protected Health Information (PHI) as part of regular responsibilities. UH employees must abide by all requirements to safely and securely maintain PHI for our patients. Annual training, the UH Code of Conduct and UH policies and procedures are in place to address appropriate use of PHI in the workplace.


This job is no longer available.

University Hospitals

Chardon, OH