Apply for Job Job ID369828 LocationTwin Cities Job FamilyResearch Full/Part TimeFull-Time Regular/TemporaryRegular Job Code8352CR Employee ClassCivil Service Add to Favorite Jobs Email this Job About the Job 30% - Regulatory Documentation: Prepare all regulatory documentation for clinical trials, including IRB applications, appendices, and consent forms. Complete documentation and regulatory forms for sponsors and the FDA. Prepare grant documents and budgets for the Office of Sponsored Projects. Maintain compliance, training, and delegation of authority logs. Keep accurate records on drug dispensing and reconciliation. Prepare annual reports to the FDA. Coordinate and participate in site initiation visits, monitoring visits, IRB post-approval review visits, and closeout visits. 30% - Clinical Trial Coordination and Operational Study Support: Coordinate clinical trials, including identifying potential study subjects based on enrollment criteria. Explain studies in detail to potential subjects and conduct the consent process. Enroll subjects and maintain frequent patient contact during the study. Schedule, facilitate, and attend all study visits. Complete and submit case report forms to sponsors in a timely manner. Respond to sponsor queries and assess subject compliance with protocol requirements. Complete annual continuing review forms for the IRB. Maintain records of all study correspondence between investigators, IRB, sponsor, FDA, and patients. Monitor subject safety, report adverse events to IRB, sponsor, and FDA as necessary. Enter study visits into TASCS (Time and Study Collection System). Maintain updated services, visits, subject tracking, and billing grids. Field patient calls related to scheduling and billing. Coordinate with facilitators, surgery schedulers, and front desk staff as needed. Schedule, coordinate, and facilitate visits for inter-departmental studies. 10% - Data Management and Analysis: Design, develop, and maintain databases and spreadsheets for data collection. Perform statistical data analyses and interpret results. Assist in writing and editing grant proposals and manuscripts for publication and presentations. Meet with statistics professionals regarding study design, organization, and data analysis. 10% - Training, Compliance and Support: Maintain certification on all required general and protocol-specific training (e.g., GCP, Human Subjects Protection, HIPAA, EPIC). Monitor and update training records of departmental research staff. Participate in study teleconferences, webinars, and research coordinator seminars. Stay current on study protocols, amendments, and revised investigator brochures. Assist residents and fellows in designing and writing research applications and consent forms. Advise on required training to ensure regulatory compliance. Assist in resolving IRB queries and completing annual continuing review forms. Write or assist in writing study protocols for investigator-initiated trials. 20% - Departmental Administrative Support and Ad Hoc Support: Provide administrative support to the department, including scheduling via QGenda and EPIC. Prepare, process, and track departmental paperwork. Assist with onboarding and training of new research and administrative staff. Support departmental communication efforts, including drafting emails and updates. Maintain department files, records, and databases in compliance with institutional standards. Qualifications All required qualifications must be documented on application materials. Required Qualifications: BA/BS degree plus at least two years of relevant experience, or a combination of education and relevant work experience to equal at least six years. Relevant and direct experience in clinical research to include data management and following clinical research Standard Operating Procedures, the Code of Federal Regulations for clinical trials and Good Clinical Practice guidelines. Computer proficiency and ability to navigate multiple software applications. Detail-oriented with exceptional organizational, planning and problem-solving skills Ability to work in a complex environment Ability to work independently, as a part of a team and with changing priorities Possess excellent communication (written and verbal) and interpersonal skills Preferred Qualifications: Previous experience with Ophthalmology specialty Experience in both adult and pediatric studies. Relevant and direct experience with regulatory requirements including study monitoring, Institutional Review Board submissions, Investigation New Drug (IND) and/or Investigational Device (IDE) submissions. Experience with Epic or other electronic medical record system About the Department The Department of Family Medicine and Community Health at the University of Minnesota was created more than 50 years ago in response to a legislative mandate to train primary care physicians. Since then, we have been leaders in transforming the specialty through education, research, and patient care. We are the academic sponsor of seven family medicine residencies-five in the Twin Cities, two in Greater Minnesota. We are involved in medical student education activities across the Medical School's two campuses: Twin Cities and Duluth. We sponsor five fellowship programs-sports medicine, hospice and palliative medicine, behavioral medicine, clinical informatics, and human sexuality- and offer continuing medical education opportunities. We are regularly among the top National Institutes of Health-funded family medicine departments. Our faculty are actively researching health disparities, healthcare delivery, and population health. More at https://med.umn.edu/familymedicine. The Division of Physical Therapy creates and integrates innovative research discoveries, education, and practice to develop scholarly, collaborative physical therapists and rehabilitation scientists who advance health care and disease prevention for diverse communities in Minnesota and beyond. More information may be found at https://med.umn.edu/fmch/physical-therapy. Pay and Benefits Pay Range: $29.00 to $31.85 per hour, we anticipate most offers will be around the midpoint of this range, depending on education and experience. Time Appointment: 100% Appointment Position Type: Civil-Service Please visit the Office of Human Resources website for more information regarding benefit eligibility. The University 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, pharmacy and disability plans Healthcare and dependent care flexible spending accounts University HSA contributions 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 Employee... 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.
