Job Duties/Responsibilities: Duties include but are not limited to providing:
1) Clinical Research Coordination (50%): - 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.
2) Regulatory Compliance and Support (20%): - 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%)
All required qualifications must be documented on application materials.
Required Qualifications: -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 -Ability to learn 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
Preferred Qualifications -Experience with medical devices (e.g., IDEs) -Experience in the preparation of IRB applications -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
Internal Number: 329277
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.