Clinical Research Associate - Minneapolis, United States - University of Minnesota

Description

The Clinical Research Associate (CRA) advises and assists University of Minnesota faculty members in their preparation, conduct, and management of clinical trials. The Code of Federal Regulation (CFR), Good Clinical Practice (GCP) guidelines, and National Institutes of Health (NIH) research rules set standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials. Extensive knowledge and comprehension of these rules and the ability to apply them are essential to performing key components of this position.

RESPONSIBILITIES
Monitoring: (100%)
Clinical monitoring involves the oversight and administrative efforts that goes into conducting a research study. The review of all clinical trial related paperwork and data are necessary in monitoring to ensure that the integrity, safety, and validity of the research are not compromised. Most monitoring will occur remotely or on the UM Minneapolis/St. Paul campus but off-site monitoring in the Twin Cities Metro area occasionally happens.

The CRA

• Must be flexible and able to monitor research studies in several different medical specialties initiated by the University of Minnesota faculty;
• Is responsible for monitoring to the standards of the FDA Code of Federal Regulations, ICH GCP guidelines, the NIH, the Human Subjects Protection Program and other university committees, such as IRB;
• Is responsible for scheduling and performing study start-up, interim and closeout visits; - monitors subject consent and safety, protocol adherence, data integrity, regulatory documents, drug and device records, training and authorization records, eligibility and enrollment and overall conduct of the study;
• Communicates all queries and concerns to both the principal investigator and the research staff and provides training (ex. Good Clinical Practices, the need for documentation of study procedures, how to obtain informed consent, etc.) when necessary;
• Generates visit reports in a timely manner.

Other Functions

• Assists with file management and organization for studies, including providing tools, templates, and guidance for setting up regulatory files.
• Attends staff meetings. He/she is responsible for tracking and reporting on all current and upcoming projects. The CRA attends various CTSI meetings and workshops.
• Meets standards in the areas of cooperation/teamwork, maintenance of effective working relationships, dependability and commitment, and execute independent decision-making and problem solving skills.
• Involved in continuing education opportunities and support the programs within the CTSI and University of Minnesota.
  • Provide training and educational presentations to groups regarding GCP and study conduct both inside and outside the University.

All required qualifications must be included in the application materials

REQUIRED QUALIFICATIONS

• BA/BS and at least 4 years of research experience or an advanced degree and 2 years of research experience or a combination of related education and work experience to equal eight years.
• Experience to include at least two years of full time work as a clinical research associate, clinical trial monitor or clinical research coordinator.
• Ability to work independently, make decisions and prioritize the simultaneous management of multiple clinical trials.

PREFERRED QUALIFICATIONS

• Familiarity with the University of Minnesota Medical Center-Fairview hospital and clinics.
• Working knowledge of Epic, OnCore, and eBinders or similar Clinical Trial Management System.

The University of Minnesota Clinical and Translational Science Institute (CTSI) mission is to accelerate and improve clinical and translational science research, education and improve health. CTSI provides consultation, training, support, and services to researchers and research teams across the translational continuum. CTSI is part of the national, NIH-funded Clinical Translational Science Award (CTSA) program/consortium that works together to improve the efficiency, quality, and impact of clinical and translational research and science.

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.

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 or call UOHR

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:

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 do not automatically disqualify finalists from employment.

The University of Minnesota, Twin Cities (UMTC)

The University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate, graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation's most vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service organizations.