Clinical Research Quality Assurance Coordinator
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; 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; 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; audits investigational drug service records, essential documents and research laboratory logs to ensure study compliance; processes and tracks corrective action plans for identified study deviations from internal and external monitor reports until resolution, submits reported serious adverse events that require a Med Watch report to Office of Research Subject Protection for reporting to the FDA; maintains 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 Associate (SOCRA) and 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 possesses health career skills including principles and techniques, medical terminology, drugs, patient education and counseling, experience with electronic medical records. Experience with electronic data capture databases and research subject software systems, experience with Microsoft Office Suite (Word, Excel, Outlook, etc.), and knowledge of ICH/GCP and FDA Regulations. They will also have experience and ability to make independent decisions based on Clinical Research Services Standard Operating Procedures and clinical research practices, will be detailed oriented, self-directed, and have the ability to perform duties and problem solve with minimal supervision. They will have excellent verbal and written communication skills, will be proficient in prioritization, multi-tasking, and organization and the ability to work independently as well as a member of a team while placing high value on quality assurance.
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