Research Professional 4 - Military Veterans

The University of Minnesota School of Dentistry is hiring a Research Professional 4!

If you're interested in expanding your portfolio of professional experience into the important world of oral health research, this opportunity might be for you.

The pay range for this position $70,000-$78,000 depending on the experience you bring to the position.
This position can support a hybrid work schedule, with the minority of days working remotely and will vary depending on the research study assignments.
This position is based on the University of Minnesota's East Bank campus in Minneapolis in the School of Dentistry.

This Researcher Professional 4 manages and coordinates research programs and projects for faculty in the School of Dentistry at the University of Minnesota. This research is done in the Oral Health Clinical Research Center in the School of Dentistry.

JOB DUTIES/RESPONSIBILITIES

Manage Clinical Research Studies 60%

Manage clinical research projects including marketing, recruitment, execution of informed consent, compliance with HIPAA requirements, determination of subject eligibility, monitoring subject responses to protocol defined treatments/interventions, scheduling required visits, follow-ups and maintaining subject tracking systems consistent with study protocol and timelines.
Facilitate the successful implementation of the IRB (Institutional Review Board) approved protocol; review and execute the study protocols; assess study related needs; and provide input to facilitate implementation
Prepare space for study related equipment and supplies, plus monitoring those supplies and investigational products
Coordinate participant study visits and ensure complete source documentation
Complete sponsor case report forms (CRFs), coordinate monitoring visits and arrange for lab visits and imaging if necessary
Complete and manage adverse event (AE), serious adverse event (SAE) and deviation logs per university/sponsor requirements
Obtain and maintain the necessary training for safety, regulatory and data management (i.e., Oncore and CITI)
Train/educate ancillary staff regarding roles in studies

Study Regulatory Management 30%

Prepare and complete IRB (Institutional Review Board) applications, informed consent documents, and data collection forms as well as completing continuing review reports and regulatory reports in a timely manner
Prepare and complete other regulatory documents, including delegation of authority logs, financial disclosure forms, and FDA forms
Maintain a regulatory/essential documents binder for each study
Assure compliance with all regulations and sponsor stipulations as necessary
Maintain accurate list and status of research activities within area of responsibility

Protocol Development 10%

Assist with writing and editing research and technical materials including IRB applications, protocol, consent forms, manuscripts, abstracts, website content, and user guides
Manage additional workload as assigned during staffing changes
Provide process improvement and Clinical Research Coordinator (CRC) perspective for workflow improvement
Contribute towards Center's goals and strategy

Please detail all the required qualifications on your application materials

REQUIRED QUALIFICATIONS

BA/BS plus at least 5 years of research experience, or advanced degree plus 3 years of research experience, or a combination of related education and research experience to equal nine years
Demonstrated ability to work well independently and with a team
Demonstrated ability to adhere to Good Clinical Practice (GCP), FDA Regulations, and HIPAA, particularly relating to human subjects and secure study files
Experience with direct patient contact
Excellent critical thinking, decision making and communication skills
Demonstrates organizational and prioritizing skills

PREFERRED QUALIFICATIONS:

Experience recruiting, consenting, and enrolling patients in clinical research studies.
Project management experience in healthcare/academic environments.
Experience with IRB submissions and IRB reporting requirements.