Medical Device Clinical Research Manager Jobs in Racine, WI

Registered Nurse, Clinical Research Coordinator

About City of Hope,
City of Hope's mission is to make hope a reality for all touched by cancer and diabetes. Founded in 1913, City of Hope has grown into one of the largest and most advanced cancer research and treatment organizations in the U.S., and one of the leading research centers for diabetes and other life-threatening illnesses. City of Hope research has been the basis for numerous breakthrough cancer medicines, as well as human synthetic insulin and monoclonal antibodies. With an independent, National Cancer Institute-designated comprehensive cancer center that is ranked top 5 in the nation for cancer care by U.S. News & World Report at its core, City of Hope’s uniquely integrated model spans cancer care, research and development, academics and training, and a broad philanthropy program that powers its work. City of Hope’s growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and cancer treatment centers and outpatient facilities in the Atlanta, Chicago and Phoenix areas.

Under direct supervision of their Clinical Research leader, the incumbent is responsible for supporting clinical trials at the top of their nursing license scope, for existing and novel oncology therapies while working in a fast-paced environment. Trial responsibility ranges from First in Human and Phase I-Phase III clinical trials, in addition to Investigator Initiated Trials( IIT’s). The CRN position has a specific responsibility for all aspects of coordination of therapeutic clinical trials in all oncology disease represented at the site. The CRN also has a specific responsibility in placing all protocol related orders in the EMR in additional to collecting biospecimens required by study protocol, while adhering to the scope of the nursing license.

The successful candidate:

• Demonstrates an in-depth knowledge of applicable federal regulations, institutional guidance documents and SOPs for the conduct of clinical trials to ensure human subject protection, compliance with protocol and regulatory requirements and the thorough collection, recording and maintenance of data and source documentation.
• Collaborates with Investigators in review of subjects’ recruitment and pre-screening for protocol eligibility. The CRN is responsible for developing an individualized strategy for identifying potentially eligible patients for each study. The CRN presents trial concepts and details to the research subjects, participates in the informed consent process, enrolls, and coordinates care of subjects in compliance with protocol requirements. The CRN may provide teaching on investigational agents/devices to research subjects and maintains test article accountability. In collaboration with Investigators, the CRN monitors subjects for changes in condition, adverse events, concomitant medication use, protocol compliance, response/reactions to test articles, and thoroughly documents all findings. The CRN is responsible for accurate and timely data collection, documentation, and reporting.
• Schedules and/or participates in off-site investigator meetings, pre-site selection visits, site- initiation visits, site-assessments, monitoring visits, and auditing activities as delegated by the Director, Clinical Research and/or Research Manager. The CRN may be responsible for and/or assist with completion and maintenance of regulatory documents in accordance with regulations, hospital and organizational policies and Standard Work Instructions. The CRN will participate in required training and education programs, provide clinical research education to local clinic staff, and ensure site research quality by practicing in compliance with policies, SWIs, principles of Good Clinical Practice (GCP) and applicable federal, state, and local regulations. The CRN may develop or assist with development of study tools including source documents and eligibility checklists and criteria cards and may be involved in the collection, processing, and shipping of protocol required lab specimens. The CRN maintains adequate supplies to conduct the studies and orders replacements as needed. The CRN maintains the equipment inventory (per protocol) and has appropriate certifications as required by protocol activities e.g., IATA certification. The CRN assists clinicians (LPNs, MAs, and/or RNs) as needed to ensure that protocol- required specimen collections, electrocardiograms, vital signs, study drugs and customary usual care medications, IV start and IV discontinuation as well as follow-up observations are performed per protocol (as applicable).
• The Clinical Research Nurse will provide consistent oversight to ensure competent and standardized practices and coordinate strategies to enhance departmental communication and collaboration.
• Must be able to work ONSITE M-F, 7:30a-4:00p in Zion, with 10-20% travel to other 2 locations.

Qualifications

Your qualifications should include:

• Prior clinical research, Nursing, and/or coordinator experience
• Bachelor’s degree in nursing (BSN)
• Valid State Board of Nursing issued IL RN License ​
• Basic Life Support (BLS) through the American Heart Association within 1 month of employment
• ACRP, SOCRA, or other within 3 years of employment
• International Air Transport Association (IATA) within 1 month of employment
• Good Clinical Practice (GCP) within 1 month of employment
• Human Subjects Protection (HSP) within 1 month of employment

City of Hope is an equal opportunity employer.

City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location.