Research - Laboratory/Non-Laboratory, Staff/Administrative
The Clinical Research Associate 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.
Monitoring: (80%) Clinical monitoring consists of the oversight and administrative efforts that goes into conducting a research study. 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. The CRA must be flexible and able to monitor research studies in several different medical specialties initiated by the University of Minnesota faculty. The CRA 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. The CRA is responsible for scheduling and performing study start-up, interim and closeout visits. The CRA 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. The CRA 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. The CRA generates visit reports including outstanding and/or non-resolved queries/issues in a timely manner.
ClinicalTrials.gov Support: (10%) The CRA is the main contact for the initial registration of research studies into the ClinicalTrials.gov website. CRA aids in account setup and maintenance of PI accounts on clinicaltrials.gov. These maintenances include password, username assistance, reminders for occasional updates (every six months), and communicate any errors on the site to the PI for correction. CRA’s responds to questions regarding the use of ClinicalTrials.gov and assures all PI’s receive prompt responses to inquiries and requests for registration assistance.
IND/IDE Assistance Program: (5%) Assist with application assembly and submission. Advise on what requirements are needed for IND/IDE submission. Remind PIs of annual review submission. Answer questions regarding regulations and GCP.
Other Functions: (5%) - The CRA is assist with file management and organization for studies, including assisting investigators with setting up regulatory files prior to the start of recruitment. - The CRA attends weekly staff meetings. He/she is responsible for tracking and reporting on all current and upcoming projects. The CRA attends various CTSI meetings and provide training or educational presentations to this group. - The CRA also 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. - The CRA is expected to be involved in continuing education opportunities and support the programs within the CTSI and University Of Minnesota. The CRA is expected to present related topics to groups regarding GCP and study conduct both inside and outside the University. The CRA will obtain and maintain clinical research associate certification, either a CCRP from SoCRA or CCRA from ACRP.
Required Qualifications: (All required qualifications must be documented on application materials.)
- BA/BS and at least 4 years of experience or an advanced degree and 2 years of experience or a combination of related education and work experience to equal eight years. - Experience must 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. - The Clinical Research Associate (CRA) will obtain and maintain clinical research associate certification, either a CCRP from SoCRA or CCRA from ACRP.
Preferred Qualifications: - Master’s degree in a related field. - Familiarity with the University of Minnesota Medical Center-Fairview hospital and clinics. - Working knowledge of Epic and OnCore or similar Clinical Trial Management System - Previous experience as a CRA for drug and medical device trials. - Experience in psychiatric research, research with children/adolescents, and/or vulnerable populations
Internal Number: 332306
About University of Minnesota, Twin Cities
The University of Minnesota, founded in the belief that all people are enriched by understanding, is dedicated to the advancement of learning and the search for truth; to the sharing of this knowledge through education for a diverse community; and to the application of this knowledge to benefit the people of the state, the nation, and the world.