Clinical Research Assistant

Department

BSD MED - Cardiology - Johnson Research Staff

About the Department

The Section of Cardiology was founded in 1950 and has a proud history. We are now charting a new course that will propel us to the forefront of cardiovascular medicine. The strength of the Section reflects the quality and dedication of its faculty, trainees and support staff and is enhanced by the rich environment at the University of Chicago.

Job Summary

This position conducts research according to study protocols that investigate lifestyle and behavioral health interventions for adults with chronic diseases. Under the direction of the Principal Investigator (PI) or designee, the Clinical Research Assistant is responsible for independently performing delegated tasks and procedures involving human subject research. This work includes medical chart reviewing, patient screening and consenting, coordination of regulatory activities, intervention fidelity monitoring, and collection and management of data for behavioral intervention study protocols related to cardiovascular disease management. This is not a remote work position.

Responsibilities

• Assist with the development, implementation, and refinement of research processes and procedures as well as data collection processes.

• Obtain consent of research participants in accordance with the IRB approved protocols and all applicable regulations including HIPAA.

• Assist with recruiting, screening, selecting, maintaining and terminating study subjects for multiple protocols.

• Schedule and conduct participant study visits, tests and/or interviews/telephone follow up calls.

• Ensure accuracy and completion of all regulatory documentation, including local or central IRB and study data. Provide data/support to study Investigators, sponsors and/or external monitors/auditors.

• Extract data from complex medical records with expert accuracy.

• Assist with financial /operational aspects of grant and contracts.

• Direct the activities of research support staff. Assist with the training of staff.

• Present study status reports related to assigned research projects.

• Track and maintain study related information in the data management system within the required timeframe.

• Contribute to the design, development, and documentation of study related data and collection tools, (e.g., questionnaires, treatment data and/or therapeutic checklists).

• Responsible for monitoring the inventory of research related supplies.

• Responsible for ordering project materials and supplies.

• Document and collect data/ samples for research related procedures performed during participant study visits.  Ensure clinicians and/or PI accurately document their study activities according to protocol.

• Monitor strict adherence to all study protocols, including all regulatory requirements adhering to appropriate federal, local and institutional guidelines. Identify and resolve issues with protocol compliance. Keep principal investigator and manager aware of any issues regarding compliance.

• Comply with all safety and infection control standards appropriate to this position.

• Adhere to Good Clinical Practice (GCP) guidelines and all human subject protection practices Perform other duties as required.

• Create systems for project implementation and data collection, including source documentation.

• Maintains system to provide patient compensation and schedule transportation for participants.

• Participate in required clinical research education and training programs.

• Assist with the preparation of research team meetings (meeting agenda, minutes, etc.).

• Performs all tasks in basic clinical studies.

• Assists with and performs various administrative and operational tasks as assigned under direct supervision.

• Acquires and applies knowledge of clinical studies to collect analyzable clinical research data and/or samples.

• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).

Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

Certifications:

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Preferred Qualifications

Education:

• Master's degree in a scientific or health related