Emergency Medicine Research Support Professional
8352P1 Research Professional 1
Medical School/Dept of Emergency Medicine/717 Delaware St. SE
Kathleen Miller, Research Program Manager
Probation: 12 months
Percentage of appointment: 0.75
Work Hours: A majority of worked hours will occur during usual business hours. There will be some evening and weekend responsibilities.
The Department of Emergency Medicine is home to a highly trained group of research coordinators who respond to research enrollments 24/7/365 through an on call system. The team conducts research studies funded by the NIH through its SIREN research network and collaborates with other departments to support their 24/7/365 research studies (Neurology, Radiology, etc.). The team enrolls patients into research studies at several local hospitals and clinics.
This position reports to the Research Program Manager and works collaboratively with research nurse professionals, physicians and other research staff. This position will provide coordinator support to principal and co-investigators including consent, data collection, shipping and handling of data files or specimens. This position is responsible for maintaining the database of regulatory documents for many studies, creating and delivering regular communications for researchers, and performs other research tasks under supervision. The position will also have administrative tasks for the department and research work unit.
Duties and Responsibilities include but are not necessarily limited to:
Research Duties (90%):
- Enroll appropriate participants into clinical trials with regards to the established protocol, Good Clinical Practice, and University of Minnesota Policies.
- Become certified per sponsor requirements for all studies (protocol training, data entry, etc.)
- Know protocol(s) to effectively and appropriately enroll patients within study parameters.
- Proficient in consent process and documentation (including EFIC consent processes).
- Accurately enter data for WEBDCU (R) randomization process and Case Report Form entry.
- Learn and access resources at each site to assist as needed (Emergency Department, Neurology, Neurosurgery, pharmacy, Research Assistants, lab, nursing).
- Attain and maintain certification in study-specific assessments and protocols and named on Delegation of Authority log.
- Perform assessments (per Delegation of Authority log) for subject follow-up visits (NIHSS, BI, SSFQOL).
- Perform routine telephone or in-person follow-up visits for research subjects and enter data accurately under the direction of the supervisor, PI or Lead study coordinator.
- Perform data analysis, interpretation and presentation; providing experimental errors and statistics on these data. Maintain study databases and accurate data entry.
- Manage approximately 5 different databases in WebDCU database system, as well as others specific to smaller studies.
- Quality improvement: post-enrollment or screen failure, review accuracy of key data points and consent version number; review timeliness of on call personnel during short enrollment window.
- Determine regulatory requirements by communicating with sponsor project managers, central and local IRBs, and local study coordinators.
- Supervise regulatory compliance of local and satellite sites and provide guidance on regulatory requirements to over 100 site managers and investigators.
- Ensure regulatory compliance by generating custom reports.
- Redact PHI for study database submissions, when applicable.
- Survey creation, data collection, and tabulation for IRB and sponsor reports.
- Quantitative: clean and tabulate data using SPSS, providing standard deviation and statistics where necessary; create data visualization using SPSS for IRB and NIH sponsor reports as requested.
- Qualitative: review data for potential red flags on the basis of demographic information or other vulnerable population information.
- Perform maintenance of study equipment: Ensuring equipment is functioning properly and troubleshooting issues and training clinicians on their use during enrollments.
- SHINE glucostabilizer software on sponsor provided laptops
- ESETT devices including software upgrades, battery life, capturing drug refills and maintaining device connectivity.
- Other research/departmental responsibilities
- Assist in the data collection for Grant reports or submissions.
- Assist in credentialing new coordinators at enrolling hospitals
- Complete all training requirements for research studies. (CITI, HIPAA, Fairview NERS training, study protocols, database training)
Financial reporting (5%):
- Administer and revise the on call augmented pay system in accordance with budget constraints and HR law. Make subjective decisions about hourly rates, pay rate tier system, augment period, and more, with final approval by Program Manager.
- Manage and edit a data collection Excel workbook for collecting project information of all coordinator hours. Maintain a project database of hours, which is used for billing ISO and ESO projects, and determining effort.
- Gather project sheets needed for biweekly payroll from research team members and alert program manager regarding irregularities.
- Instruct employees on the time sheet instructions, including creating job aids and presentations.
- Process travel reimbursements and manage purchasing requisitions.
- Assist with department projects as requested by Department Manager or Department Head.
- Complete other University training appropriate for key responsibilities: People Soft, Purchasing (P Card), requisitions.
- Publish a weekly “Research Snapshot” by compiling weekly statistics and key timely information and disseminate electronically to the user list.
- Publish 2 quarterly newsletters to two different research networks and members.
- Collaborate with coordinators to design and publish brochures, instruction check lists, etc.
- Prepare materials for outreach events.