HRI offers a competitive salary and comprehensive benefits package.
Description of Duties:
The Clinical Research Quality Assurance Coordinator is responsible for the coordination, facilitation and monitoring of Roswell Park clinical research studies at Roswell Park external sites, including study start-up activities, site initiation, site monitoring and study close out visits. The Clinical Research Quality Assurance Coordinator establishes regular lines of communication and interfaces with external sites to build relationships, provides monitoring support for all facets of Roswell Park clinical studies with emphasis on organizational (investigator-initiated) studies, conducts monitoring activities intended to facilitate and assure that clinical studies comply with the requirements of the approved study protocol, the Roswell Park Institutional Review Board (IRB) and applicable Food and Drug Administration (FDA), as well as all other regulatory requirements, and reviews study-related processes relative to applicable regulatory requirements, including the FDA's International Conference of Harmonization Good Clinical Practices (ICH-GCP) standards and standard operating procedures, as applicable. They also audit investigational drug service records, essential documents and research laboratory logs to ensure study compliance, process and track corrective action plans for identified study deviations from internal and external monitor reports until resolution, submit reported serious adverse events that require a Med Watch report to Office of Research Subject Protection for reporting to the FDA, and maintain in strict confidence all confidential information regarding clinical studies and clinical research study sponsors.
Applicants must have Current certification by the Association of Clinical Research Professionals (ACRP); or Current certification by the Society of Clinical Research Associates (SOCRA). They must also have a Master’s degree and the equivalent of three years of full-time research experience, two years of which must have been in clinical research; or a Bachelor’s degree and the equivalent of five years of full-time research experience, three years of which must have been in clinical research. The preferred candidate will have experience with electronic data capture (EDC) and clinical trial management system (CTMS). They will also have a working knowledge of ICH/GCP and FDA regulations. The preferred candidate will have the ability to work independently as well as part of a team and be able to travel to research sites conducted across the country. They will be able to think critically, prioritize, be extremely detail oriented and will have excellent written and communication skills.
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
Applicants must reference the Posting # when applying for this position.
Interested applicants may apply by uploading a cover letter and resume below in Microsoft Word or PDF format.