Shire Jobs

Job ID360194 LocationTwin Cities Job FamilyResearch-Support Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352P1 Employee ClassCivil Service About the Job We are seeking a Clinical Research Coordinator (Research Professional 1) in the Interventional Psychiatry Program under the direction of Dr. Ziad Nahas. The lab is located primarily at the Interventional Psychiatry Program's St. Louis Park clinic, with additional study activity at UMN and M Health Fairview sites on the UMN campus. Our work focuses on advancing translational research of mood dysregulation and depressive disorders. Specific interests and areas of expertise include: * Improving patient care of treatment resistant disorders using neuromodulation techniques. * Functional neuroimaging (fMRI), electroencephalography (EEG) and brain stimulation modalities: Transcranial magnetic stimulation (TMS), transcranial alternating current stimulation (tACS), vagus nerve stimulation (VNS), prefrontal cortical stimulation (PCS), deep brain stimulation (DBS), electroconvulsive therapy (ECT) and focal electrically administered seizure therapy (FEAST). * Increasing equitable access to neuromodulation interventions for patient care. Job Duties/Responsibilities: (45%) Study Management 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. *Maintain working knowledge of assigned protocols and disease background. *Maintain good clinical practice and open communication with patients/family members. *Schedule and complete return study visits. *Complete case report forms and respond to monitor 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 study monitor visits as directed by study sponsor. *Work with regulatory on study amendments and re-consenting process. *Communicate with principal investigator to ensure study specific procedures are completed. *Effectively work independently in multiple locations with hospital and clinic staff to complete research related tasks. (30%) Recruitment Responsible for patient recruitment, screening, consent, enrollment, and registrations for clinical studies in people with mood and/or substance use disorders *Maintain a working knowledge of patient eligibility and protocol specific requirements. *Participate in recruitment efforts for new study participants. *Perform screening related activities as per protocol specific guidelines. *Consent and explain study to new patients/family members. *Facilitate patient accrual to assigned protocols. *Collect/obtain all 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 patient assessments. (20%) Data management Perform study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records, and personal communications with other healthcare workers. *Maintain working knowledge of medical terminology, critical lab values, and understanding of medical conditions. *Maintain working knowledge of various sponsor specific databases and portals. *Review patient charts and records to abstract appropriate research related information. *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 patient phone call or record search. (5%) Laboratory activities, as needed Protocol set up, sample processing, pa kaging 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. *Collecting samples from subjects. *Communicating with laboratories across campus to ensure proper handling and delivering of samples. *Shipping to central laboratories. Qualifications Required Qualifications: *BA/BS or a combination of related education and work experience to equal four years. *Proficiency with Microsoft Office software *Available to work a flexible schedule. *Possess excellent communication skills; verbal and written. *Exposure to electronic database/form development (REDCap or equivalent) *Exposure to clinical trials, investigational device and / or drug *Exposure to the Informed Consent Process Preferred Qualifications: *Detail oriented *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) *Experience with clinical trials regulatory tasks, investigational device and / or drug 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 . 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 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) Financial counseling services Employee Assistance Program with eight sessions of counseling at no cost Please visit the 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... 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.