All required qualifications must be documented on application materials.
- BA/BS with at least two (2) years of experience or a combination of related education and work experience to equal 6 years
- Experience must include a minimum of one (1) year experience in clinical research setting in an academic health center
- Experience in the preparation of IRB applications
- Working knowledge of regulations governing research activities (such as GCPs, FDA regulations and ICH guidelines
- Demonstrated ability to initiate and process multiple projects simultaneously
- Experience with Office Suite, Google Apps, and web-based systems for tracking activities, calendaring, and retrieving/updating information.
- Possess excellent communication skills; verbal and written.
- Demonstrated ability to provide excellent customer service to internal and external clients
- Experience with medical devices (e.g., IDEs)
- Knowledge of medical terminology
- Certification as a clinical research professional with SoCRA or ACRP or willingness to obtain certification at time of eligibility.
- EPIC experience
About the Job
Job Duties/Responsibilities:Duties include but are not limited to providing:
1) Clinical Research Coordination (50%):
2) Regulatory Compliance and Support (20%):
- Contribute to study start-up activities, including site initiation visits, OnCore set-up, document template and flow sheet creation, study staff training and clinical in-services.
- Patient recruitment, screening, consent, enrollment, and necessary registrations.
- Perform study testing.
- Perform study data collection and entry; collect enrollment and treatment data, using charts, correspondence, electronic medical records, and personal communications with other healthcare workers.
- Perform protocol procedures and specimen collection and processing.
- Coordinate/conduct quality control checks as related to study conduct.
- Maintenance of subject research charts.
- Coordinate study close-out activities.
- Responsible for the interpretation of, application of, and compliance with federal regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as they relate to assigned research protocols.
- Under supervision of MnDRIVE Regulatory Specialist, creates regulatory files for new studies;
- Completes IRB and other required review committee applications on assigned protocols;
- Drafts study-related subject informed consent form documents according to Sponsor and University requirements;
- Drafts study-related correspondence, including preparing FDA submissions, for study PI;
- Under supervision of MnDRIVE Regulatory Specialist, creates and maintains all required documents for assigned regulatory binders;
- Assist PIs, Regulatory Specialist, Core Project Manager in preparation for audits/monitoring visits
3) Data Management (10%)
- Responsible for data management, data collection, data entry, and appropriate data storage for multiple DBS projects.
- Creates REDCap databases and enters study data
4) Outreach activities (10%)
- Plan and participate local and regional outreach activities aimed at promoting awareness of MnDRIVE research study portfolio
5) Other duties as assigned (10%)
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:
About the Department
The MnDRIVE DBS Research Core provides research support services to Investigators across the University. Brain conditions, including Parkinson’s disease, stroke, epilepsy and mental illness, are chronic afflictions that diminish a person’s quality of life. The conditions affect one in five Americans. The social and economic impacts are devastating, with annual U.S. health care and lost productivity costs estimated at nearly $500 billion. Through high-impact research and discovery in the field of neuromodulation, MnDRIVE trains the next generation of scientists and clinicians, and brings new and improved therapies to Minnesotans suffering from brain conditions. The initiative will expand University partnerships with industries to bring neuromodulation innovations to market, which benefits patients and advances the state’s economy.
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 Activities" page and uploading documents there.
To request an accommodation during the application process, please e-mail email@example.com or call (612) 624-UOHR (8647).
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.