Clinical Research Coordinator III - Pediatrics Genetics

Clinical Research Coordinator III – Center for Rare, Undiagnosed, and Genetic Disorders Scheduled Hours: 40. This highly skilled individual will be the main point of contact for investigators wishing to initiate n‑of‑1 or small clinical trials in rare and genetic diseases, and may assist in interventional sponsored studies. The coordinator oversees and coordinates complex or multi‑site clinical research studies, provides comprehensive information to clinical research staff, promotes smooth operations, prepares regulatory compliance documents, and may supervise clinical research staff. Primary Duties & Responsibilities Act as the primary liaison to the PI, developing plans for research projects and discussing interpretation of results. Collaborate in preparing manuscripts for publication and grant proposals to sponsoring agencies; assist in preparing protocol amendments and modifications. Develop forms, questionnaires, and research techniques; write instructional procedure manuals for study progress, data collection, and coding. Review journals, abstracts, and scientific literature to keep abreast of new developments. Prepare sponsor‑investigator INDs and assist PI/ investigators in navigating regulatory requirements for investigator‑initiated studies (including emergency and individual INDs as well as traditional INDs). Design, implement, and manage all phases of the study/protocol; ensure compliance with protocol guidelines and regulatory agency requirements. Identify problems, monitor participants’ progress, document and report adverse events, and resolve IRB/protocol management issues. Serve as liaison with funding or sponsoring agencies; consent study participants; coordinate study visits alone or with research unit staff. Handle IRB submissions (initial, continuing review, and ad hoc), including adverse events; report AE to MedWatch; communicate with study monitors and data & safety monitoring boards. Provide guidance to research team, train new staff, and serve as lead or point of reference for other coordinators on scheduling, performance feedback, and staff matters. Evaluate and interpret collected clinical data; prepare oral or written presentations and reports, analyze progress trends, and provide recommendations. Perform other incidental duties related to the work described above. Working Conditions Job location: normal office environment. Physical effort: typically sitting at a desk or table. Equipment: office equipment. Required Qualifications Bachelor’s degree in a related field or equivalent combination of education and experience (minimum 3 years clinical research experience). Basic Life Support (BLS) certification from American Heart Association or American Red Cross, obtained within one month of hire. Proven experience in clinical research, including protocol development, regulatory compliance, and participant monitoring. Hands‑on experience with institutional review board (IRB) submissions, adverse event reporting, and data management. Preferred Qualifications Master’s degree in a related discipline. SOCRA/ACRP certification (preferred). Experience in clinical study protocols, database management, spreadsheet analysis, statistical software (SAS) and supervision of staff. Salary Range Grade C11: $56,200.00 – $87,100.00 per year (based on qualifications and performance). Benefits Up to 22 days vacation, 10 recognized holidays, and sick time. Competitive health insurance packages with priority appointments and lower copays/coinsurance. Free Metro Transit U‑Pass for eligible employees. Defined contribution retirement savings plan (403(b)) with university matching starting at 7%. Wellness challenges, annual health screenings, mental health resources, mindfulness programs, employee assistance program, and financial resources. 4 weeks caregiver leave to bond with a new child. Tuition coverage for employees and dependent undergraduate-level college tuition up to 100% at WashU and 40% elsewhere after seven years. EEO Statement Washington University in St. Louis is committed to equal employment opportunity. It is the University’s policy to provide equal opportunity and access to people in all job titles without regard to race, ethnicity, color, national origin, citizenship, age, religion, sex, sexual orientation, gender identity or expression, disability, protected veteran status, or genetic information. #J-18808-Ljbffr Washington University