Clinical Research Regulatory Specialist I, Ophthalmology
University Hospitals
full-time
Posted on:
Location Type: Hybrid
Location: Cleveland • Ohio • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Comprehends knowledge of scientific concepts related to the design and analysis of clinical trials;
- Ensures care of the participants, aspects of human subject protections and safety in the conduct of a clinical research study.
- Encompasses study management and GCP compliance; safety management (adverse event reporting) and handling of investigational product.
- 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.
- Embraces the principles and practice of leadership and professionalism in clinical research.
- Performs other duties as assigned.
Requirements
- Bachelor's Degree and some related experience (Required) or Associate's Degree with 4 years of clinical and/or research experience (Required)
- Ability to prioritize the work of multiple projects. (Required proficiency)
- Detail-oriented person with the ability to work independently on multiple tasks and manage time effectively. (Required proficiency)
- Write and edit technical documents. (Required proficiency)
- Ability to understand and communicate regulatory requirements to others. (Required proficiency)
- Medical terminology. (Required proficiency)
- Excellent verbal, written, interpersonal skills. (Required proficiency)
Benefits
- Complies with all policies and standards.
- For specific duties and responsibilities, refer to documentation provided by the department during orientation.
- Must abide by all requirements to safely and securely maintain Protected Health Information (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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial designclinical trial analysisGCP complianceadverse event reportinginvestigational product handlingtechnical writingregulatory requirements understandingmedical terminology
Soft skills
teamworkleadershipprofessionalismcommunicationdetail-orientedtime managementindependent workinterpersonal skills
Certifications
Bachelor's DegreeAssociate's Degree