Regulatory Research Coordinator I

Post #
7713
Company
Health Research Inc. (HRI) Roswell Park Division
Department
Clinical Research Services
Hours/Shift
Full-time; Days
Salary
HRI offers a competitive salary and comprehensive benefits package.
Description of Duties

Health Research, Inc. (HRI) Roswell Park Division is seeking a 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.

Qualifications

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 in health science, will be a certified Clinical Research Professional through SoCRA or ACRP or similar Clinical Research Organization and will be proficient skills in MS Office programs especially Word and Excel. They will also have excellent verbal and written communication skills, including virtual presentation skills, two years of Clinical Research experience and previous regulatory research experience. They will have strong attention to detail, the ability to multitask in a busy working environment, will enjoy working in an exciting, fast paced, deadline driven environment, and will have the ability to verbalize knowledge of applicable clinical regulatory requirements.

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