- Clinical Research Coordinator to coordinate and perform daily clinical research activities in accordance with approved protocols administered by the non-cancer Clinical Trials Management Organization for the Dermatology Division in the Department of Internal Medicine;
- assists with assessing patient records to identify patients who are eligible to participate in specified clinical research protocols;
- recruits, interviews and enrolls patients; obtains informed consent and ensures consent process is administered in compliance to regulatory and sponsor requirements;
- educates patients and families of purpose, goals, and processes of clinical study; coordinates scheduling and follow-through of patient care appointments, procedures, amp;
- other diagnostic testing in accordance with study protocol; participates in the collection, processing amp; evaluation of biological samples;
- administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires;
- assists with monitoring patients for adverse reactions to study treatment, procedure or medication and notifies appropriate clinical professional to evaluate patient response, identify status of complications, amp;
- provide appropriate level of care; documents unfavorable responses and notifies research sponsors amp; applicable regulatory agencies;
- participates in evaluating patients for compliance related to protocol; assists with collecting, extracting, coding, and analyzing clinical research data;
- generates reports and reviews to ensure validity of data; supports activities to ensure compliance with all Institutional Review Boards (IRB), FDA (Federal Drug Administration), federal, state and industry sponsor regulations;
- assists with coordinating and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors;
participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements.
Minimum Education and Skills / Experience Required / Desired :
- Bachelors Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required;
- one year experience in a clinical research capacity required; experience or knowledge in diseases of the skin preferred;
knowledge of medical terminology desired; clinical research certification from an accredited certifying agency desired; computer skills required with experience using Microsoft Software applications desired.
Requires successful completion of a background check. Qualified candidates may be requested to complete a pre-employment physical, including a drug screen.
FUNCTION / SUBFUNCTION : Research and Scholarship / Clinical Research
CAREER BAND : Individual Contributor-Specialized
CAREER LEVEL : S2
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