The University of Minnesota School of Dentistry is hiring a Research Professional 3!
If youâ™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 Minnesotaâ™s East Bank campus in Minneapolis in the School of Dentistry.
This Researcher Professional 3 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 Centerâ™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.
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.