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Washington University of St. Louis Senior Protocol Coordinator - Clinical Trials Unit - 51320 in St. Louis, Missouri

Job Type/Schedule This position is full-time and works approximately 40 hours per week. Department Name/Job Location This position is in the Department of Internal Medicine, Clinical Trials Unit. The position is located at the 620 S. Taylor. This position is for the Medical School Campus. Essential Functions POSITION SUMMARY: Position is responsible for providing support to WUSM Principle Investigator and/or research staff in preparation, submission and maintenance of research regulatory files. Responsible for facilitating the flow of research submissions (new and renewal), revisions, amendments, and adverse event reports through the various institutional review and registration processes. Collaborates with investigators in addressing ethical and regulatory issues identified by review and regulatory entities. PRIMARY DUTIES AND RESPONSIBILITIES: 1. Maintains unit essential documents in audit ready order. 1. Delegation of duty logs 2. Site visit logs 3. Screening and enrollment logs 4. Informed consent logs 5. Signed protocol and investigational product documents 6. Study specific regulatory materials 7. Safety/Adverse event reports 2. Processes new protocol submissions, continuing review, and study modifications through various approval and registration steps, internal Washington University processes (currently EPIC and Oncore). 3. Conducts, documents weekly unit meetings, coordinates study feasibility site visits, site initiation visits, monitoring visits and study close out meetings. 4. Collects and maintains research staff CVs, Human Subjects and Good Clinical Practice Training records, professional licenses and various study related certifications. 5. Collects and maintains CAP, CLIA, CVs lab normal from laboratories and other facilities used for research activities. 6. Documents, prepares and ships regulatory records suitable for long term archive to storage facility with the ability to recall these records as needed. Required Qualifications High school diploma or equivalent high school certification with two to four years of college required and two to four years of related work experience (preferably within a medical environment). Preferred Qualifications * Data entry and word processing skills. * Internet, web and cloud experience. * Typing, grammar and writing skills. Salary Range The hiring range for this position is $21.18 - $26.99 per hour. Pre-Employment Screening All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening. Benefits This position is eligible for full-time benefits. Please click the following link to view a summary of benefits: https://wustl.box.com/s/8wkhs25yssf0775x9d6nd6vqa7obpth7. EOE Statement Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status. Job Title: Senior Protocol Coordinator - Clinical Trials Unit - 51320 Job ID: 51320 Location: Medical School Full/Part Time: Full-Time Regular/Temporary: Regular

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