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, & other diagnostic testing in accordance with study protocol; participates in the collection, processing & 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, & provide appropriate level of care; documents unfavorable responses and notifies research sponsors & 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
Bachelor’s Degree in biological sciences, health sciences, social sciences or other medical field or an equivalent combination of education and experience required.
Experience Required
One year experience in a clinical research capacity required.
Desired Experience
2-4 years of relevant experience preferred. Experience or knowledge in cognitive diseases/disorders preferred; knowledge of medical terminology desired; computer skills required with experience using Microsoft Software applications desired.
Desired Certification
Clinical research certification from an accredited certifying agency desired (ACRP or SOCRA).
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
Additional Information:
This is a patient facing position and is required to be onsite.
Location: Kenny Rd, 2006-2030 (0214)
Position Type: Regular
Scheduled Hours: 40
Shift: First Shift
Final candidates are subject to successful completion of a background check. A drug screen or physical may be required during the post offer process.
