Research Support - Laboratory/Non-Laboratory, Staff/Administrative
1. Study Start-up and Close Out:
• Contributes to study start-up activities, including site initiation visits, document template and flow sheet creation, study staff training and clinical in-services. • Helps Clinical Research Coordinator with study budgets • Helps to coordinate/conduct study logistics and oversees quality control checks as related to start-up and close-out. • Works with Clinical Research Supervisor to coordinate study close out activities.
2. Study Conduct:
• Patient recruitment, screening, consent, randomization, enrollment and necessary registrations. • Manages assigned protocols/studies by creating study specific time points for each study assigned • Provides education to, subjects, and families about protocols, treatment, procedures, possible side effects and complications. • Performs study data collection and entry into various electronic databases. Experience with REDCap, Oncore and UMN IRB Ethos systems. • Collect enrollment and treatment data, using charts, correspondence, electronic medical records, and personal communications with other healthcare workers. Communicates with /monitors/registries regarding data collection. o Submits protocols into Ethos and Oncore for approval. o Uses REDCap to develop data collection tools for studies. o Using box, excel and other Microsoft products as study tools o Reports information to sponsors using sponsor specified databases/programs. o Coordinates quality control checks on the data entered into the above mentioned systems • Maintains and monitors patient case records for accuracy, quality of data, timeliness of submission, and compliance with protocol. • Works on regulatory items for audits/monitoring visits. • Reviews correspondence and other source documents for specific study information regarding the protocol to identify timetable activities. o Keeps detailed information on timelines and has good organizational skills as it pertains to each study they are assigned. • Reviews clinic and hospitalization records in a timely and organized manner in order to assure communication is up to date. Communicates with the labs and works to coordinated ordered labs and test procedures required by each study assigned. • Arranges collection of protocol-defined research specimens. Processes and ships research specimens per protocol. • Works with IDS to assist with study drug inventory and accountability. • Demonstrates effective and efficient communication with study sponsors, monitors, Clinical Research Supervisor, Department and University staff including Project Investigators (PIs), and Fairview health team members. • Assist study monitors with site initiation visits, monitoring visits, and close out visits.
3. Regulatory/Study Monitor Compliance:
• Ensures timely submission of study/regulatory documentation. Assist with consent form changes and keep study-specific administration binders up-to-date. • Identify potential study risks, take steps to promote subject safety, and implement plan to address. • Works with the Protocol PI and the Clinical Research Supervisor to evaluate s adverse event data. • Process adverse events as required for each study subject and for each study, including on-going communication with PI, co-PIs, primary physicians of study subjects, study sponsors, IDS (Investigational Drug Pharmacy Service), and IRB. • Recommends corrective action for individual studies when appropriate • Works with CTSI and the Clinical Research Coordinator on regulatory items when needed • Responsible for the interpretation of, application of, and compliance with Federal Regulations, Good Clinical Practice (GCP), and University and Clinical Partner policies as it relates to assigned research protocols. • Keeps all required training up to date. • Reports to the Clinical Research Supervisor and keeps them up to date on any and all study activities or issues as they arise.
REQUIRED QUALIFICATIONS (must be documented on application/resume): - BS/BA in a health related field and 4 years’ experience in research setting or an advanced degree and 2 years’ experience or an equivalent combination of education and experience to total eight years. - Experience completing and submitting regulatory documents (IRB applications, continuing reviews, other required regulatory reporting, etc). - Experience working with Institutional Review Boards (IRB). - Knowledgeable on federal regulations and good clinical practice. - Experience independently meeting deadlines and prioritizing assignments. - Experience with computerized data management in a professional setting. - Work experience in verbal and written communication. - Work experience initiating and processing multiple projects simultaneously. - Experience in a PC environment including Microsoft Office Word and Excel. - Work experience documenting situations clearly and concisely in written communications. - Work experience providing customer service to internal and external clients.
Preferred Qualifications - Good with technology including: REDCap, Oncore, Ethos, UMN Box and Fairview Hospital EPIC. - Has experience using excel, and other Microsoft applications. - Motivated self-starter - High level of organization skills. - Experience with study recruitment via websites - Experience working in a hospital setting.
Internal Number: 337669
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.