Research Support - Laboratory/Non-Laboratory, Staff/Administrative
The Clinical Research Coordinator works as an assistant to the research nurses in phase II-IV pharmaceutical drug or device trials as well as independently managing registry and non-therapeutic studies.
(40%) Subject / study coordinator – Assist nurse coordinator with therapeutic trials and/or independently coordinate registry trials. -Facilitate patient accrual to assigned protocols. -Consent and explain study to new patients/family members. -Perform screening related activities as per protocol specific guidelines. -Register patients and schedule return study visits. -Complete case report forms and respond to monitor issues queries. -Complete adverse event (AE) logs and other study documentation. -Complete required forms for any serious adverse events (SAE) and report and notify appropriate departments / sponsors per requirements -Schedule/conduct study monitor visits as directed by study sponsor. -Maintain working knowledge of assigned protocols and disease background. -Work with nurse coordinator and regulatory to update patient on study amendments and re-consenting process. -Communicate with principal investigator to ensure study specific procedures are completed. -Facilitate non-nursing functions (specimen processing, shipping, vital signs, EKG, 6 minute walk etc). -Maintain good clinical practice and open communication with patients/family members. -Effectively work independently in multiple locations with hospital and clinic staff to complete research related tasks
(40%) Data management -Complete electronic case report forms (eCRFs) in protocol database for therapeutic trials. -Respond to monitor issues queries. -Enter patient registration and visit dates in various internal databases (Oncore and TASCS). -Document patient related visits in medical chart as necessary. -Review patient charts and records to abstract appropriate research related information. -Maintain working knowledge of medical terminology, critical lab values, and understanding of medical conditions. -Site data manager and staff contact for issues arising with data management or entry. -Maintain working knowledge of various sponsor specific databases and portals. -Manage follow up schedule and perform follow up via patient phone call or record search.
(20%) Assist nurse coordinator with completion of non-nursing study procedures on therapeutic trials. -Assist with consenting/screening process for new study patients. -Participate in recruitment efforts for new study participants. -Maintain a working knowledge of patient eligibility and protocol specific requirements. -Perform non-nursing study visit activities (perform EKG, lab collection/processing/shipping, patient questionnaires). -Collect/obtain all samples or imaging to be sent to study sponsors. -Procure outside medical records and information as needed for study. -Assist with other documentation as directed. -Provide back up support for nurse coordinator as appropriate when coordinator is unavailable. -Secondary coordinator contact to field protocol questions or potential patients -Facilitate physician review of study specific lab reports and patient assessments. -Schedule/coordinate monitoring visits with study sponsors.
Required Qualifications (must be documented on application materials): -BA/BS or a combination of related education and work to equal 4 years of experience in a clinical or research setting in related field. -Experience in a medical laboratory setting with phlebotomy and equipment used in the collection, processing, classification, measurement, or analysis of specimens or data. -Proficiency with word and excel computer software; available to work a flexible schedule.
Preferred Qualifications: -Certified Medical Assistant or Certified Nursing Assistant. -Knowledge of clinical research compliance standards, e.g. informed consent process, adverse event reporting, the Federal Code of Regulations and Good Clinical Practices (GCP) Standards; experience interviewing and interpreting data from written reports and interviews. -Experience with Research databases and study spread sheets using Excel or programs. -Organized with excellent attention to detail.
Internal Number: 332021
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.