Rockefeller University Clinical Research Specialist in New York, New York
Job Title Clinical Research Specialist
Laboratory / Department Hospital
The Rockefeller University Hospital is funded by the National Institutes of Health and has 20 patient beds for clinical research. The Hospital provides researchers with an opportunity to conduct clinical studies, and offers both normal volunteers and people with diseases under study the opportunity to stay in the hospital and help to contribute to important advances in science. The Hospital has an inpatient unit as well as an outpatient center where prospective patients are screened and many outpatient studies are conducted. The Hospital is staffed 24 hours a day with professional nurses and has nutritional research, social work, art and recreation departments, and a radiology suite as well as its own research pharmacy. Our staff hospitalist and on-call physicians provide additional medical support to the clinical research teams. For more information, please see the hospital web site at: http://www.rucares.org/
The Clinical Research Specialist will conduct for-cause/not-for-cause, and new investigator-audits, and track deviations for early intervention, and provide regulatory training and support to investigators. Will be responsible for supporting clinical trial registration, maintaining SOPS, supporting Good Clinical Practice (GCP) newsletter and online Investigator Manual, and identifying process/practice opportunities for performance improvement. Will participate in research and scholarly activities to advance the science of regulatory support.
Bachelor's degree in science required; Master's degree, educational emphasis in psychology, healthcare, communications or statistics, and CCRA certification preferred. Must have a minimum of three years of experience in clinical research conduct and administration, hands-on experience in GCP, research conduct, documentation, audit/monitoring, and direct dealings with the FDA re: IND/IDE applications or other compliance filings. Must be organized, punctual, detail and deadline-oriented. Must work well with investigators, team members, and supervision, and possess excellent communication skills.
The Rockefeller University is an Equal Opportunity Employer - Minorities/Women/Disabled/Veterans