The primary purpose of this position is to provide clinical trials assistance to University faculty performing clinical research in the understanding and treatment of pulmonary disease, including but not limited to cystic fibrosis and COPD. Duties are determined by protocol-specific requirements and may include any research activity from protocol development through study closeout. This position involves working with pediatric and adult patients.
The primary purpose of this position is to support pulmonary clinical research projects according to regulatory requirements, institutional guidelines, and sponsor expectations. Duties are determined by protocol-specific requirements and may include initiating new trials, coordinating the enrollment of eligible patients, extracting and reporting quality patient data and tissue samples, and responding to data queries. This position reports to the Research Manager, but is accountable to the physician-investigators, program leaders, and members of the clinical research team.
70% - Research Project Coordination • Coordinate pulmonary human subject research from concept to study closeout. • Data management of research projects including data collection and data entry into databases while ensuring data quality • Act as information resource to University faculty and staff for protocol specific queries, including availability of trials and enrollment requirements • Engage with investigators in verifying subject eligibility, facilitating subject enrollments, and ensuring compliant completion of research activities. • Ensure timely and accurate data submission; engage with providers and investigators to ensure adequate source documentation is available; accurate interpretation and recording of data; maintenance of subject research charts. • Facilitate the timely review and reporting of adverse reactions and severe adverse events
20% - Research Regulatory Management • Support regulatory staff in preparing regulatory approval applications; responding to stipulations, and ensuring IRB approval for research activities. • In collaboration with the PI and study team, interpret study protocols and inform the development of consent forms and other participant materials needed for each clinical research study • Maintain regulatory binders and required documentation for each clinical research study to ensure compliance and to be audit-ready at any given time • Prepare for and participate in site initiation visits, monitoring visits, program audits, etc. • Report Unanticipated Problems according to University policy
5% - Administration • Support quality improvement initiatives • Some travel is required to attend national and study meetings as appropriate
5% - Education • Support the training and mentoring of other CRCs within the program • Educate University faculty and staff about the protocol and of our regulatory and research obligations in relation to our clinical research activities • Communicate with clinical teams to foster an environment of quality research participation within the context of exceptional clinical care
All required qualifications must be documented on application materials.
Required Qualifications • BA/BS in Respiratory Care or related and 2 years of relevant experience or an equivalent combination of education and experience to total 6 years • Valid MN Respiratory Care Practitioners License • Flexibility with work schedule to accommodate subject visits • Experience in the use of Microsoft Office • Ability to work independently and with the multidisciplinary team as needed; make decisions, problem solve and prioritize the simultaneous management of multiple clinical studies • Possess excellent interpersonal communication skills with patients and healthcare professionals; verbal and written • Ability to follow strict protocols with utmost ethical standards • During a typical 8 hour shift, a person in this position may be required to stand up to 2.5 hours, walk up to 2.5 hours (including stairs), reach above shoulders, lift up to 10 pounds above the shoulder, and carry packages across campus at waist level
**Proof of non-active tuberculosis and immunization for or resistance to measles, mumps, rubella, Hepatitis B, pertussis and influenza are required. A background check will be completed by the University of Minnesota Medical Center Fairview as a condition of employment in this position.
Preferred Qualifications • Registered respiratory therapist • Demonstrated experience in Respiratory Care • Relevant research certification, such as CCRP or CCRC • Experience recruiting to research studies • Experience with Epic electronic medical record system • Experience with administration of inhaled medication • Experience performing pulmonary function testing • Experience with the care of patients with cystic fibrosis, COPD or other lung disease
Internal Number: 335482
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.