Research Support - Laboratory/Non-Laboratory, Staff/Administrative
The Cardiovascular Division is a growing, dynamic clinical research unit that supports the physician’s research portfolio in all sections of Cardiology including: Interventional, Heart Failure, Imaging, Vascular Disease, Structural Heart Disease, Prevention, Resuscitation and Electrophysiology to name a few. 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.
(25%) 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.
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.
(20%) Laboratory activities Laboratory functions: Phlebotomy, protocol set up, sample processing, packaging and send out as required per protocol.
Must be able to follow standard operating procedures for select instruments and/or methods to meet requirements of the research. Includes: collecting samples from subjects, communicating with laboratories across campus to ensure proper handling and delivering of samples, shipping to central laboratories, setting up protocol specific procedural manuals and documentation throughout study. Must be able to assist, supplement and occasionally function as general back-up to the Lab Manager of a small clinical research lab.
All required qualifications must be documented on application materials.
Bachelor’s degree in a health related field plus 2 years of work experience in research; or a combination of related education and work experience in research totaling 6 years. Experience must include 2 years of clinical research coordinator experience.
Experience and knowledge in a medical laboratory setting with phlebotomy and equipment used in the collection, processing, classification, measurement, or analysis of specimens or data.
Proficiency/experience with word and excel computer software; available to work a flexible schedule.
Certified Medical Assistant or Certified Nursing Assistant.
Experience working in a CLIA-compliant laboratory setting; understanding of laboratory regulations and good laboratory practice; training in IATA Hazardous Materials Shipping.
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 CRF databases.
Organized with excellent attention to detail.
Internal Number: 330988
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.