To apply please visit: https://hr.myu.umn.edu/jobs/ext/327481 and search 327481
About the Job
Monitor implementation, management, coordination and documentation of all study activities. Ensure that components of the project are completed in an ethical, scientifically rigorous, and timely manner. Ensure lab personnel/volunteers are compliant with safety regulations and lab specific protocols are established and followed.
The distribution of effort will change over time. It is anticipated that much of the first 6 months efforts will be in Lab Management Support. As regulatory steps are completed and enrollment of subjects begins, there will be a switch to Protocol/ Study Management.
Lab Management Support - 50%
Act as a lead/mentor/trainer on primary study protocol and within the research team for other active studies.
Support the supervision of undergraduate student volunteers as needed.
Assist in the analysis of data and preparation of annual NIH reports, presentations and manuscripts
Support the development of new grants and protocols (as needed)
Conduct literature reviews and database development
Protocol/Study Management - 50%
Support the day-to-day management of research protocols under the general direction and oversight of the PI.
Work both independently and within a team structure on tasks such as, but not limited to:
recruitment and phone screening;
visit scheduling and logistical support;
visit implementation, informed consent process, administration of assessments (as appropriate), study drug distribution management, sample collection, processing and shipment (as applicable)
data management (collection and storage)
regulatory management (IRB, adverse event reporting, etc), subject tracking, and general office paperwork and organization
Handle financial, personnel, and administrative transactions (ex. study participant payments and supply purchasing)
Anticipated research will occur at both the VA and the UMN CMRR and will include (but not limited to) administration of experimental drug and neuroimaging.
All required qualifications must be documented on application materials.
Must have BA/BS in a science or health related field plus 2 years of work experience in research coordination; or a combination of related education and work experience in research coordination totaling 6 years
Proficiency/experience with Microsoft Office software and comfortable with data capture systems such as RedCap
Available to work a flexible schedule based on study and patient needs
Demonstrated ability to work independently, make decisions, problem solve and prioritize
Possess excellent communication skills; verbal and written.
Some general experience with mentoring, training, or as a team lead
General knowledge of GCP and federal regulations as a whole, but is proficient in the guidance that pertains to clinical trial administration and investigational drug projects.
Assuming the availability of funds, this individual should have an interest in preparing for Certification as a Clinical Research Coordinator (ex. SoCRA or ACRP)
Experience working with a Veteran population is highly desirable
Internal Number: 327481
About University of Minnesota
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.