Regulatory Research Coordinator II
Health Research, Inc. (HRI) Roswell Park Division is seeking a full-time Regulatory Research Coordinator II. The Research Coordinator II supports the research and treatment mission of Roswell Park and Clinical Research Services in a senior role that provides education and mentorship and also 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 be Certified as a Clinical Research Professional through Society of Clinical Research Associates (SoCRA); or Association of Clinical Research Professionals (ACRP); or Other comparable research-related certification recognized by Roswell Park Comprehensive Cancer Center as appropriate for this title. The applicant must have a Bachelor's degree and the equivalent of three year full-time experience in clinical research: or an Associate's degree and the equivalent of four years of full-time experience in clinical research . The preferred candidate will have a Bachelor’s degree; Current applicable Regulatory Research Experience in Clinical Research Services; Experience with team meeting interactions, report preparation and tracking; Experience entering and working in research database such as OnCore platform (CTMS); current experience preparing submissions in electronic submission system such as CLICK IRB System; Current experience with Regulatory essential files and electronic eRegulatory type systems. They will also have current applicable knowledge of SOP and Work Instruction development; Subject Protection CITI course completion; Proficiency with MS Office application skills especially MS Word, MS Excel and MS Outlook; Experience with pharmaceutical sponsor monitor visit interactions and study start up activities. They will possess excellent skills with electronic systems; Ability to manage and prioritize high volume of emails; Possess excellent organizational, virtual presentation skills 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