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Regulatory Research Coordinator III
Health Research Inc.
Clinical Research Services
First Shift (United States of America)
Supports the research, education and treatment missions of Roswell Park and Clinical Research Services in a senior level/team leadership role that also provides education and mentorship and manages 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 (GCP).
Required Education and Experience
1. Current certification by the Association of Clinical Research Professionals (ACRP); or
2. Current certification by the Society of Clinical Research Associates (SOCRA); or
3. Other comparable research-related certifications recognized by Roswell Park Comprehensive Cancer Center as appropriate for this title.
Education and Experience
1. Bachelor's degree and the equivalent of five (5) years full-time experience in clinical research: or
2. Associate's degree and the equivalent of six (6) years of full-time experience in clinical research.
1. Incumbents must obtain certification through the Association of Clinical Research Professionals (ACRP) or the Society of Clinical Research Associates (SOCRA) or from other comparable research-related certifications recognized by Roswell Park Comprehensive Cancer Center as appropriate for this title within one (1) year of appointment as a condition of continued employment.
2. Required degrees must have been granted by an accredited college or university or one recognized by Roswell Park Comprehensive Cancer Center as following acceptable educational practices.
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.
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.
Roswell Park Cancer Institute Corporation (RPCIC) and Health Research Inc. (HRI) Roswell Park Division believe that all persons are entitled to equal employment opportunities, and we do not discriminate against our employees, applicants or job seekers because of their race, color, religion, sex, sexual orientation, gender identity or expression, national origin, creed, age, disability, pregnancy-related condition, military or veteran status, marital or familial status, domestic violence victim status, citizenship status, genetic information, individual's relationship or association with a member of a protected category or any other protected group status as defined by law.
Additionally, RPCIC and HRI Roswell Park Division are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please send an e-mail to HR-Benefits@RoswellPark.org or call (716) 845-4700 and let us know the nature of your request and your contact information.
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