Department: MED-Clinical Trials Unit
Salary/Grade: EXS/8

Job Summary:

Under general supervision and according to standard practice or general instruction, directly supports the research initiatives of the Bluhm Cardiovascular Institute Clinical Trials Unit. Collaborates with the physicians and clinical team in implementing investigator-initiated, industry-sponsored, as well as federally funded protocols, including multi-center clinical trials. Responsible for coordinating research studies from the initiation of the study to its completion, including but not limited to implementing clinical and non-clinical study procedures. Conducts protocol eligibility assessments, provides ongoing clinical and laboratory evaluation of study subjects, collects data and maintains confidential research records, provides study patient management according to protocol and regulatory requirements.

Please note: Supervisor provides objectives and deadlines.  Work is reviewed for fulfillment of objective and deadlines and overall compliance with policy and procedures.  EE completes some activities without direction, informing supervisor only of potentially controversial matters, and/or far-reaching implications.    Work may extend beyond the central NU/NM campus to NM affiliates for targeted initiatives.

Specific Responsibilities:

• Recruit, screen, enroll, and follow study participants over the course of a study as outlined in assigned cardiovascular research protocols. The study nurse will perform physical examinations on potential participants prior to randomization.
• Coordinates the implementation of clinical protocols at Northwestern and subsites. Works with sponsors, study staff, laboratory staff, data managers, pharmacists, clinic staff, investigators, and other departments to develop and implement protocol-specific standard operating procedures.   Coordinates clinical and non-clinical study start-up activities including organization of study medical records and coordination of required laboratory and clinical evaluations. 
• Performs patient recruitment and evaluates subjects for potential study qualification in accordance with protocol eligibility criteria, including: medical record review, interviewing, clinical and laboratory evaluations, obtaining informed consent. The study nurse will collect information necessary for reporting serious adverse events (including details of the hospitalization)
• Provides ongoing monitoring of patients in clinical research protocols.  Conducts medical and social histories, clinical evaluations and orders laboratory and other procedures as required by protocol.  Records/abstracts data in study source documents and on case report forms.  Schedules and tracks study visits.  Ensures that study drug is properly dispensed to patient and provides patient education regarding medications and laboratory results.  Also oversee accountability of investigational devices and provides associated education. Reviews clinical and laboratory data on study patients. Notifies principal investigator of any abnormal values and ensures follow-up and reporting of adverse events in accordance with regulatory requirements. 
• Responsible for ongoing data collection and maintenance of confidential records. Reviews study forms, files and reports for completeness, accuracy, consistency and compliance (quality control).  Ensures appropriate and timely transmission of clincal data to data management center. Responds in a timely manner to requests for data clarifications and queries.  The study nurse will assemble medical information (results of physical examination, ECG, vital signs) for review  and presentation prior to randomization. The study nurse will review research billing 

Miscellaneous

• Performs other duties as assigned.

Minimum Qualifications:

• BS in nursing with a minimum of 3 years in an administrative or clinical research role in an academic or industry environment or the equivalent combination of education and experience where similar knowledge, skills, and abilities may be acquired.
• RN Licensure in Illinois required.

Minimum Competencies: (Skills, knowledge, and abilities.)

• Ability to work on multiple projects simultaneously.
• Strong computer skills to include advanced use of Word and Excel software programs, internet, and email.
• Ability to identify research and solve problems.
• Must possess ability to articulate and clearly communicate study information to patients and other health care professionals
• Attention to detail and highly organized.
• Excellent clinical assessment skills.
• Able to make decisions independently and yet must be team oriented.

Preferred Qualifications:

• Master of Science degree
• Cardiovascular experience

Benefits:
At Northwestern, we are proud to provide meaningful, competitive, high-quality health care plans, retirement benefits, tuition discounts and more! Visit us at https://www.northwestern.edu/hr/benefits/index.html to learn more.

Work-Life and Wellness:
Northwestern offers comprehensive programs and services to help you and your family navigate life’s challenges and opportunities, and adopt and maintain healthy lifestyles.
We support flexible work arrangements where possible and programs to help you locate and pay for quality, affordable childcare and senior/adult care. Visit us at https://www.northwestern.edu/hr/benefits/work-life/index.html to learn more.

Professional Growth & Development:
Northwestern supports employee career development in all circumstances whether your workspace is on campus or at home. If you’re interested in developing your professional potential or continuing your formal education, we offer a variety of tools and resources. Visit us at https://www.northwestern.edu/hr/learning/index.html to learn more.

Northwestern requires all staff and faculty to be vaccinated against COVID-19, subject to limited exceptions. For more information, please visit our COVID-19 and Campus Updates website.

The Northwestern campus sits on the traditional homelands of the people of the Council of Three Fires, the Ojibwe, Potawatomi, and Odawa as well as the Menominee, Miami and Ho-Chunk nations. We acknowledge and honor the original people of the land upon which Northwestern University stands, and the Native people who remain on this land today.

Northwestern University is an Equal Opportunity, Affirmative Action Employer of all protected classes, including veterans and individuals with disabilities. Women, racial and ethnic minorities, individuals with disabilities, and veterans are encouraged to apply. Click for information on EEO is the Law.
  

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