60%: Implements, coordinates and performs daily clinical research activities in accordance with approved protocols; 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; ensures initial and follow-up appointments are appropriately scheduled and fulfilled for participants to receive patient care services according to protocol; coordinates scheduling and follow-through of surgeries, medical procedures, & other diagnostic testing; collects and documents medical histories; participates in the collection, processing & evaluation of biological samples; administers, evaluates and calculates standardized scoring of diagnostic, psychological or behavioral testing or questionnaires – (also remove any type of test or questionnaire that is not applicable; for example, if administering and scoring behavioral questionnaires, but not diagnostic or psychological tests, then only include description about the behavioral tests); coordinates and documents care of patients; 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.
15%: Assists with collecting, extracting, coding, and analyzing clinical research data; compiles and enters clinical research data into study database; generates reports and reviews to ensure validity of data; assists with development of clinical research study database; assists with writing sections of manuscripts, articles and other media for publication and presentation.
10%: Participates in activities to develop new research protocols and contributes to establishment of study goals to meet protocol requirements; assists with planning and development of clinical study processes.
10%: Prepares and submits regulatory documents to applicable governing agency related to the conduct of human subject research; 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 planning, organizing and preparing for external quality assurance and control reviews by IRB, federal or industry sponsors; completes case report forms.
5%: Attends departmental meetings; attends national professional and scientific conferences to continue professional development; completes special projects as required.
20% collecting and organizing data