University of Rochester Clinical Research Coordinator - 226884 in Rochester, New York
Clinical Research Coordinator Job ID 226884
School of Medicine & Dentistry
Full/Part Time Full-TimeFavorite Job
Full Time 40 hours Grade 051 Medicine M&D-Nephrology Div
8 AM-4 PM
The Coordinator will work closely with the Principal Investigator(s) to coordinate federally funded research studies in the Division of Nephrology. The current projects involve recruitment of patients with chronic kidney disease, kidney transplant, or on hemodialysis, but additional studies are anticipated. This individual must be able to work independently with minimal supervision in a fast-paced environment with multiple projects running simultaneously. Excellent interpersonal skills are required, as the individual will interface with research subjects/patients, their families, Nephrology providers, and other study team members as needed to achieve project goals and objectives.
Responsibilities will include:
25% - Provide research support to multiple principal investigators and research staff on Nephrology related studies. Serve as liaison between study personnel, investigators, physicians, clinic staff, patients and their families in all phases of clinical research for the Division of Nephrology. Plan and execute required aspects of the research project working with the PI, physicians, clinic staff, patients and their families and other health care professionals which may include, but are not limited to, the following:
Screen and identify eligible subjects for enrollment into research protocols by participating in clinics and reviewing clinic schedules and electronic records
Maintain patient data such as consent forms, letters, and appointment notices. Provide scheduling of study events for patients enrolled.
Collect clinical data for duration of patient’s participation in the study, i.e., medical record review, functional data, biological data; complete side effects/adverse effects reporting
Review and evaluate patient data for statistical analysis
Identify problems, obstacles, or barriers to successfully completing research protocols; recommend solutions/revisions to the study team leadership.
25% - Acts as liaison with sponsor monitor to provide data clarifications, to review study protocols and ensure thorough understanding, to clarify protocols as questions arise during the study, to communicate adverse events as advised by the PI, and to ensure regulatory and other documents (i.e., consents, CRF’s) are completed and on file for sponsor’s review. Communicates with sponsor to clarify final data queries and determine final report format. Prepares for scheduled sponsor monitoring visits (i.e., pre-study inspection, initiation, on-going and close-out). Communicate protocol changes and updates to clinical staff.
20% -Collect, analyze, and disseminate research and site performance data. Report program data and progress to study team. Work with PI to develop, implement, and maintain comprehensive databases and files related to programs including data cleaning, query response, and report generation to any study coordinating center.
20% - Serve as point of contact for patients concerning study matters. Maintain and prepare detailed documentation of treatment and follow-up of enrolled patients. Update documentation of patient procedures and/or data as they occur.
5% - Follow Research Subject Review Board regulations and complete reporting requirements, and ensure compliance with institution and central regulatory agency requirements.
5% - Other duties as assigned
Bachelor’s degree and 1-2 year’s experience in clinical research coordination; or equivalent combination of education and experience. Certified Clinical Research Coordinator and nursing degree preferred. Knowledge of software preferred.
PLEASE CHECK ALL THE APPROPRIATE CATEGORIES OF PATIENTS SERVED BY THE EMPLOYEE:
_ neonate _ pediatric _X18-65 years _Xover 65 yrs.
JCAHO (MA18.104.22.168) requires that the performance appraisals of staff without clinical privileges who participate in the assessment, treatment, or care of patients address the ages of the patients served. Technical staff, including phlebotomists, are included in this definition.
How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled