Assist with and oversee the day-to-day operations of clinical trials and studies
Work as a team member in coordination of assigned primary studies.
Obtain study subject’s medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
Interview prospective subjects for a variety of research clinical trials.
Educate potential subjects on the details of the studies through phone contacts and personal interviews
Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
Collect, code, and analyze data obtained from research in an accurate and timely manner
Perform data and sample collection at in person and telephone research visits
Blood and tissue specimen handling and processing
Enter data and send to coordinating center (if indicated)
Adhere to research regulatory standards
Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
Maintain familiarity with study protocols and documents of assigned research studies
Work with investigators and other staff to prepare IRB submission and maintain study approval and certification
Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
Participant recruitment, consent and retention
Ensure that the necessary supplies and equipment for studies are in stock and in working order
Inventory, handle, and maintain accountability for study supplies and investigational products in collaboration with research pharmacy |