Clinical Research Associate, Twin Cities, Minnesota

Created 06/13/2021
Employer University of Minnesota
Reference 11399873
Job Type Full Time
Country United States
State Minnesota
City Twin Cities
Zip 55401
Salary Competitive
The UMN has suspended hiring for most positions. However, we will continue hiring for positions critical to the University's mission and operations at this time. Applications are being accepted for this position and you are encouraged to apply. In-person interviews are suspended indefinitely and will be replaced by interviews in a virtual format. Thank you for your continued interest in working at the University of Minnesota.

Qualifications

All required qualifications must be documented on application materials

Required Qualifications
- 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.
- 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

About the Job

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.

Responsibilities:

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:
- 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.

About the Department

The Clinical and Translational Science Institute (CTSI) at the University of Minnesota (UMN) is supported through the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, grant 8UL1TR000114. The institute is one of 60 medical research institutions working together to improve the way clinical and translational research is conducted nationwide, enhancing its efficiency and quality. The consortium aims to accelerate the process of translating laboratory discoveries into treatments for patients, to engage communities in clinical research efforts, and to train a new generation of clinical and translational researchers. For more information, visit http://www.ctsi.umn.edu. The University of Minnesota offers a comprehensive benefits package including: - Competitive wages, paid holidays, vacation and sick leave - Low cost medical, dental, and pharmacy plans - Health care and dependent daycare flexible spending accounts - Excellent retirement plans with employer match - Disability and employer paid life insurance - Wellbeing program with reduced insurance premiums - Tuition reimbursement opportunities covering 75%-100% of eligible tuition - Student loan forgiveness opportunity - Opportunities for growth and promotion - Employee Assistance Program For more information regarding benefits: Benefits Summary

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 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 employ@umn.edu or call (612) 624-UOHR (8647).

Diversity

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 .

Background Check Information

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.

About the U of M

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.

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