CCRA (Certified Clinical Research Associate), CCRP (Certified Clinical Research Professional), RQAP-GCP (Registered Quality Assurance Professional – GCP)
4 Year Degree
The National Institutes of Health (NIH), Clinical Center (CC), Office of Research Support and Compliance (ORSC), is looking for Protocol Monitoring Specialists who have skill in applying standards and methods of health sciences in order to serve as a technical expert to execute major studies and continuing specialized projects to ensure quality assurance of human research protocols.
As a Protocol Monitoring Specialist, you will provide routine and for-cause monitoring and auditing of clinical research protocols to ensure protocol compliance, develop individual risk-based monitoring plans, ensure operationalization of the plans, assist with investigations, collate data from routine monitoring and auditing activities, develop reports for CC and NIH leadership, and use results to develop organizational clinical research quality improvement initiatives.
The NIH Clinical Center (NIH) is the largest federally funded hospital in the world totally dedicated to biomedical and translational clinical research. The hospital has 200 inpatient beds and several outpatient clinics that support 1,600 intramural clinical research studies among the twenty-seven NIH Institutes and Centers. These positions are located in the Office of Research Support and Compliance (ORSC), of the Clinical Center (CC), National Institutes of Health (NIH). This Office is responsible for supporting investigators while ensuring the quality and integrity of the research conducted at the NIH including overseeing compliance with the regulations/guidelines.
This is a Title 5 federal appointment in the competitive service. Salary will be commensurate with experience and accomplishments. A full package of benefits (including retirement, health, life and long-term care insurance, Thrift Savings Plan, etc.) is available. Applications must be submitted via the www.usajobs.gov website by searching for announcement number: NIH-CC-DE-19-10541915 and/or NIH-CC-MP-19-10541916 for Protocol Monitoring Specialist. Applications must be submitted by midnight on the closing date of the announcement Monday, August 26, 2019 to Friday, August 30, 2019. Please include in your Cover Letter a description of mentoring and outreach activities in which you have been involved, especially those involving persons from groups which are underrepresented in biomedical research. If you have questions about this position, please contact Jacquara Graham at (301) 435-4752 or firstname.lastname@example.org. This position is subject to a background investigation.
The Department of Health and Human Services and NIH are equal opportunity employers committed to equity, diversity and inclusion.
Candidates must have a bachelors degree or graduate/higher level degree with major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of this position. (This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education at the time the degree was obtained) and 1 (one) year of qualifying specialized experience equivalent to the next lower grade of the position.
The ideal candidates will possess at least 5 years of experience in research quality assurance, clinical research, and federal regulations that govern human subjects and investigational drug and devices research (45 CFR 46 and 21 CFR 312 and 21 CFR 812).