Apply for Job Job ID362444 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 Dr. Ziad Nahas (Interventional Psychiatry Lab) in the Department of Psychiatry and Behavioral Sciences is seeking a full-time Clinical Research Coordinator (Research Professional 2) passionate about advancing knowledge in the area of translational research of mood dysregulation and depressive disorders. This is an excellent opportunity to start or grow a fascinating career in research while working with supportive faculty. This position will be dedicated to working directly with participants receiving invasive brain stimulation treatment (VNS), and a successful candidate will be responsible for ensuring that trials are run in an ethical, scientifically rigorous, and timely manner. Job Responsibilities/Duties: Study Management - 45% Monitor implementation, management, coordination and documentation of all study activities in accordance with GCP, federal regulations and institutional policies. Ensure that components of the project are completed in an ethically, scientifically, rigorous and timely manner. Continuously update safety records and procedures. Specific Study Management Duties: *Maintain working knowledge of assigned protocol *Perform screening related activities as per protocol specific guidelines *Complete case report forms and respond to monitor issues queries *Complete adverse event (AE) logs and other study documentation *Complete required forms for any serious adverse events (SAE) and report and notify appropriate departments / sponsors per requirements *Schedule/conduct study monitor visits as directed by study sponsor *Update participants on study amendments and complete the re-consenting process *Communicate with principal investigator to ensure study specific procedures are completed *Manage follow up schedule and perform follow up visits Recruitment - 30% Responsible for patient recruitment, screening, consent, enrollment, and registrations for clinical studies in people with mood and/or substance use disorders Specific Recruitment Duties: *Maintain a working knowledge of patient eligibility and protocol specific requirements *Participate in recruitment efforts for new study participants, including partnership with clinicians *Assist with consenting/screening process for new study patients *Collect/obtain all necessary samples to be sent to study sponsors *Procure outside medical records and information as needed for study *Assist with other documentation as directed *Facilitate physician review of study specific lab reports and participant assessments Data Management - 20% Perform study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records, and personal communications with other healthcare workers. Specific Data Management Duties: *Maintain working knowledge of medical terminology, critical lab values, and understanding of medical conditions *Maintain working knowledge of various sponsor specific databases and portals. *Enter patient registration and visit dates in various internal databases (Oncore and Florence) and medical chart as necessary *Site data manager and staff contact for issues arising with data management or entry *Manage follow up schedule and perform follow up via participant phone call or record search Laboratory activities - 5% Protocol set up, sample processing, packaging and send out as required per protocol. Must be able to follow standard operating procedures for select instruments and/or methods to meet requirements of the research. Specific Laboratory Duties: *Collecting samples from participants *Communicating with laboratories across campus to ensure proper handling and delivering of samples, as appropriate *Shipping to central laboratories, as appropriate *Setting up protocol specific procedural manu ls and documentation throughout study Qualifications All required qualifications must be included in the application materials Required Qualifications: *BA/BS with at least 2 years of experience or a combination of related education and work experience to equal 6 years. *Knowledge of clinical research, Good Clinical Practices (GCPs) and federal regulations related to clinical research. *Exposure to FDA regulated drug and/or device clinical trials. *Exposure with the Informed Consent Process. *Exposure to OnCore or other CTMS software tools, including electronic databases. *Proficiency with Microsoft Office software. *Ability to work independently, make decisions, problem solve and prioritize. *Possess excellent communication skills; verbal and written. *Some general experience with mentoring, training, or as a team lead. Preferred Qualifications: *Experience with FDA regulated drug and/or device clinical trials. *Experience with REDCap Database/Form Development. *Experience in mental health clinical care or research, particularly VNS or other neuromodulation devices *Experience with the Informed Consent Process *Experience with electronic medical records systems (e.g., Epic) About the Department The Department of Psychiatry & Behavioral Sciences consists of an outstanding team of researchers, clinicians, and educators who provide world-class expertise in psychiatric illness, treatment, scholarship, and scientific discovery. Our mission is to: Create and disseminate new knowledge in the science of mental health Provide effective and innovative clinical care programs to alleviate the suffering of mental illness and promote mental resilience Train the next generation of interprofessional experts who will be leaders in Minnesota and beyond Engage in compassionate and vigorous outreach and advocacy on issues relevant to psychiatric illness, treatment, and research You can find more information on our website at https://med.umn.edu/psychiatry. 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 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.