Actively seeking a Cardiac Clinical Trials Regulatory Coordinator-Clinical Research Assistant to join the Cardiac Research Team of the Department of Medicine, in the Jacobs School of Medicine and Biomedical Sciences (JSMBS).
The Clinical Trials Regulatory Coordinator is responsible to apply knowledge of clinical trial operations, Good Clinical Practice (GCP), and ICH guidelines to assure regulatory compliance in all clinical trials conducted at The Cardiac Research Team.
Primary focus to prepare study documents for trial start up including Investigator Agreements, initial IRB submissions and electronic binder creation. Participate in research of regulatory issues and provide regulatory affairs feedback and guidance throughout the study. Review changes to existing SOPs (standard operating procedures) to define the requirements for regulatory compliance. Conduct internal audits for clinical trials in order to assure the compliance of the study files with regulatory requirements, company SOPs and GCP guidelines.
Outstanding Benefits Package
- Assist with the coordination, implementation, and conduct of research projects ensuring adherence to research protocol requirements which may include: maintenance of regulatory documents and electronic binders, data management, IRB submissions and communication of such to the research team.
- Complete, collect, store, and distribute regulatory documentation required by regulatory agencies, sponsors and local SOPs.
- Utilizes electronic regulatory platform, to route and maintain regulatory documents.
- Communicates with sponsors, monitors, research personnel to ensure all aspects of study compliance.
- Collaborates with study team to schedule pre-site selection visits, site initiation visits, webinars, monitoring and close-out visits.
- Monitors and reports project status.
- Understands basic concepts of study design.
- Assists with preparation for audits and response to audits.
- Maintain up to date databases, prepare and distribute reports on regulatory activities.
- Maintains study personnel certification records (License, CV, GCP).
- Documents the education and training of research personnel as needed.
- Performs other duties as assigned.
Working at UB comes with benefits that exceed salary alone. There are personal rewards including comprehensive health and retirement plan options. We also focus on creating and sustaining a healthy mix of work, personal and academic pursuit – all in an effort to support your work-life effectiveness. Visit our benefits website to learn about our http://www.buffalo.edu/administrative-services/for-faculty-staff/benefits/r…
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As an Equal Opportunity / Affirmative Action employer, the Research Foundation will not discriminate in its employment practices due to an applicant’s race, color, religion, sex, sexual orientation, gender identity, national origin and veteran or disability status.