Clinical Research Coordinator II (West County) - Allergy & Immunology

Location SAINT LOUIS, MO 63141 Scheduled Hours 40 Position Summary Assists investigators as coordinator of a complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency, community and the study participants; manages and records all phases of study protocol as required by sponsoring agency to ensure compliance. Job Description Primary Duties & Responsibilities: Coordinates the development of forms, questionnaires, data bases and the application of research techniques; data collection and reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies. Implements and manages all phases of study/protocol; ensures compliance with protocol guidelines and requirements of regulatory agencies; establishes record-keeping systems; makes assessments and determinations of participants’ progress in the study; analyzes, investigates and reports adverse events; makes decisions as when to notify physicians of issues, when to stop participant inclusion and/or to make and/or recommend adjustment of the protocol of particular participants; resolves protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. Routinely recruits and enrolls study participants; participates in making determinations of eligibility based on diagnostic criteria and confers with participants to explain the purpose of the study and obtain completed informed consent; explains diagnostic procedures and treatment plans, and addresses participant/family questions and concerns. Performs and/or coordinates the collection of protocol-defined study procedures and clinical assessments which frequently include Questionnaires, Blood Draws, ECGs, Vital Signs, Breathing Tests (PFTs), and Study Drug Administration when necessary. Processes and ships lab specimens to central labs in accordance with study-specific guidelines. Maintains study lab collection supplies. Receives, logs, and stores study drugs in accordance with study-specific guidelines. Maintains appropriate study-related regulatory documentation including regulatory files, study participant data, and source documentation. Maintain appropriate recordkeeping and organization of many types of information and data, including database creation, data management, and data entry. Preparation and management of various regulatory documents. Facilitates and implements study start-up activities including, but not limited to: trial feasibility assessment; study logistics; IRB (both local and central) submissions and other applicable regulatory requirements; budgetary and contract review and approval. May train and supervise staff assigned to work on the research project(s). Performs other duties as assigned. Working Conditions: Job Location/Working Conditions Patient care setting. Physical Effort Typically sitting at desk or table. Equipment Office equipment. The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel so classified. Management reserves the right to revise or amend duties at any time. Required Qualifications Education: Bachelor’s degree or combination of education and/or experience may substitute for minimum education. Certifications /Professional Licenses : The list below may include all acceptable certifications, professional licenses and issuers. More than one credential, certification or professional license may be required depending on the role. Basic Life Support - American Heart Association, Basic Life Support - American Red Cross Work Experience: Clinical Research (2 Years) Skills: Not Applicable Driver's License: A driver's license is not required for this position. More About This Job Required Qualifications: Basic Life Support certification must be obtained within one month of hire date. Basic Life Support certification (Online BLS certifications, those without a skills assessment component, are not sufficient to meet the BLS requirement). Preferred Qualifications: Prior experience with EPIC and/or OnCore. Preferred Qualifications Education: No additional education unless stated elsewhere in the job posting. Certifications /Professional Licenses : Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP), Certified Clinical Research Professional (CCRP) - Society of Clinical Research Associates (SOCRA) Work Experience: No additional work experience unless stated elsewhere in the job posting. Skills: Adaptability, Clinical Research, Clinical Study Protocols, Communication, Database Management, Detail-Oriented, Epic EHR, Highly Developed Interpersonal, IRB Submission, Learning New Concepts, Learning Techniques, Microsoft Office, Multitasking, Phlebotomy, Prioritization, Regulatory Documents, Research Projects, Spreadsheet Analysis, Statistical Analysis Software (SAS) Grade C10 Salary Range $54,600.00 - $81,900.00 / Annually The salary range reflects base salaries paid for positions in a given job grade across the University. Individual rates within the range will be determined by factors including one's qualifications and performance, equity with others in the department, market rates for positions within the same grade and department budget. Questions For frequently asked questions about the application process, please refer to our External Applicant FAQ . Accommodation If you are unable to use our online application system and would like an accommodation, please email   [email protected]   or call the dedicated accommodation inquiry number at 314-935-1149 and leave a voi