Regulatory Research Coordinator I
Health Research, Inc. (HRI) Roswell Park Division is seeking a temporary full-time Regulatory Research Coordinator I. The Regulatory Research Coordinator I supports the research and treatment mission of Roswell Park and Clinical Research Services by managing the program study portfolio and coordinating the regulatory aspects of the studies assigned. Collaborates and communicates with investigators, sponsors and teams to assure research regulatory documentation is complete and the submission of new studies, amendments/modifications, continuing reviews and all other study documents are in accordance with the FDA Code of Federal Regulations (Title 21) and according to the guidelines set by the International Committee for Harmonization for Good Clinical Practices.
The applicant must have a Bachelor's degree and the equivalent of one year full-time experience in clinical research or health related field: or an Associate's degree and the equivalent of two years of full-time experience in clinical research or a health related field. The preferred candidate will have a Bachelor’s degree; Current applicable Regulatory Research Experience in Clinical Research Services; Experience with CDT meeting interactions, report preparation and tracking; Experience entering and working in the CRS OnCore platform (CTMS); current experience preparing submissions in CLICK IRB System; Current applicable knowledge of Regulatory level Clinical Research Services SOP and Work Instructions; Applicable knowledge and maintenance of Regulatory shared folder system. Current applicable knowledge of the CRS Regulatory Binder filing; Subject Protection CITI course completion; Proficiency with MS Office application skills especially MS Word and MS Outlook; Experience with pharmaceutical sponsor monitor visit interactions. They will also possess excellent skills with electronic systems; Ability to manage and prioritize high volume of emails; Possess excellent organizational and communications skills; Possess analytical skills with the ability to problem solve; attention to detail; Ability to prioritize and multi- task in an extremely busy working environment with time sensitive submissions.
This is a grant-funded position. Compliance with funding requirements such as time and effort reporting, grant deliverables, and contract deliverables is required.
Health Research Incorporated (HRI) Roswell Park Division participates in the E-Verify program.
Affirmative Action/Equal Opportunity Employer/Qualified Individuals with Disabilities/Qualified Protected Veterans