Clinical Research Coordinator II at University of South Florida responsible for coordinating clinical research activities and ensuring participant data quality. Serving as main contact for sponsors and patients for specific research protocols.
About the role
- Ophthalmology Clinical Scientist leading scientific planning and execution of clinical trials. Collaborating in a global, cross-functional team to ensure quality and integrity of trial conduct.
Responsibilities
- Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s)
- Serving as the lead clinical scientist on the clinical trial team
- Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director
- Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments)
- Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming
- Providing tactical/scientific mentorship to other clinical scientists
Requirements
- Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD Degree
- Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
- Experience in conducting global clinical trials, including trial initiation through database lock
- Experience in conducting clinical trials in ophthalmology, such as uveitis, AMD (age-related macular degeneration), thyroid eye disease
- Experience in developing protocols and study related documents for ophthalmology clinical trials
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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