Research Professional 2 - Clinical Research Coordinator

Apply for Job Job ID362578 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P2 Employee ClassCivil Service Add to Favorite Jobs Email this Job About the Job The primary purpose of this position is to support clinical research within the Division of Neonatology. The Clinical Research Coordinator facilitates the conduct of research according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties include initiating new studies, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, and responding to data queries. This position reports to the Clinical Research Project Manager, but is accountable to the program leaders, the physician-investigators, and members of the clinical research team. This is an in-person position with availability to occasionally work from home once trained and approved by supervisor. Clinical Research Conduct & Facilitation (75%) Coordinate all study-related activities, including participant recruitment, enrollment, study visits, data and specimens, and sponsor visits independently Act as information resource to University faculty and staff for protocol specific queries, including availability of trials, enrollment requirements, specimens needed, etc. Engage with investigators in verifying subject eligibility, facilitating subject enrollments, ensuring the appropriate recording of adverse events, and timely acquisition of research tissue. Ensure timely and accurate data collection and submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts. Process human specimens per protocol requirements, coordinate shipping as needed Facilitate the timely review and reporting of adverse reactions and severe adverse events Conduct data abstraction for chart review studies Contribute to the production of research publications or presentations of research data when appropriate Research Regulatory Management (20%) Lead the maintenance of regulatory binders and required documentation as directed Prepare for and participate in site initiation visits, monitoring visits, program audits, etc. Partner with Regulatory Specialist to ensure timely and complete regulatory submissions (IRB, HRPP, etc.) Report Unanticipated Problems according to University policy Education and Administration (5%) Educate others of our regulatory and research obligations in relation to our clinical research activities Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care Essential Employees The successful candidate will be designated as an Essential Employee. Essential Employees are expected to report to campus during a University State of Emergency (reduced operations or campus closure) unless specifically directed by the Department not to report or if directed by civil emergency or medical authorities not to report for health and safety reasons. As an Essential Employee, you must report to campus even if the closure is less than 3 days. This is a Hybrid position Location: Riverside Professional Building and Masonic Children's Hospital Qualifications All required qualifications must be documented on application materials Required Qualifications: BA/BS in a scientific or health related field and at least 2 years of experience in a medical setting, OR a combination of education and experience in clinical research to equal to 6 years Computer proficiency and ability to navigate multiple software applications. Detail-oriented with exceptional organizational, planning and problem-solving skills Ability to work independently, as a part of a team and with changing priorities Demonstrated ability to maintain deadlines and prioritize assignments Excellent written, verbal and interpersonal skills During a typical 8 hour shift, a person in this position may be required to stand up to 2.5 hours, walk up to 2.5 hours (including stairs), reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level. Preferred Qualifications: Experience working in clinical, social-behavioral or bench research Experience working in a pediatric medical setting Experience with computerized data management in a healthcare setting, including electronic medical records Demonstrated ability to identify data for abstraction Experience with Epic or other electronic medical record system Previous pediatric or NICU research experience Knowledge of Good Clinical Practices (GCPs) About the Department At University of Minnesota Department of Pediatrics, our experts, care teams and researchers are illuminating cures that save young lives. Our ground-breaking treatments are improving the lives of children who are ill or injured, and are becoming the standards of care for children across the country and around the world. The Division of Neonatology is dedicated to providing innovative care, conducting research, and teaching skills to recognize and treat medical problems of neonates. Benefits Working at the University At the University of Minnesota, you'll find a flexible work environment and supportive colleagues who are interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life outside of work. The University also offers a comprehensive benefits package that includes: Competitive wages, paid holidays, and generous time off Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program Low-cost medical, dental, and pharmacy plans Healthcare and dependent care flexible spending accounts University HSA contributions Disability and employer-paid life insurance Employee wellbeing program Excellent retirement plans with employer contribution Public Service Loan Forgiveness (PSLF) opportunity Financial counseling services Employee Assistance Program with eight sessions of counseling at no cost Please visit the Office of Human Resources website for more information regarding benefits. How To Apply Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume. Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section. To request an accommodation during the application process, please e-mail employ@umn.edu or call (612) 624-8647. Diversity Employment Requirements Any offer of employment is contingent upon the successful completion of a background check. Our presumption is that prospective employees are eligible to work here. Criminal convictions... For full info follow application link. The University recognizes and values the importance of diversity and inclusion in enriching the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining employees with varying identities and backgrounds. The University of Minnesota provides equal access to and opportunity in its programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status, disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about diversity at the U: http://diversity.umn.edu.