Job Description

Job Description Summary:
This position provides professional research nursing care and patient monitoring for Cardiovascular and Cardiothoracic clinical research trials, following established standards and practices. Assists in the preparation and submission of new research protocols; responsible for patient recruitment, procedures, and follow-up in the assigned clinical trials; and completion and retention of study documentation.
Job Description:
Key Roles and Responsibilities

Reviews and assists with editing of new protocols. Assesses feasibility of research protocols, including appropriate patient population, budget, and specific needs for the study.

Performs all details necessary for initiation and/or completion of all assigned research protocols, including patient recruitment, screening, scheduling, enrollment, examination, laboratory and diagnostic studies, medication dispensing, charting and recording of data (in EMR, case report forms, and Velos), organization of the study visits and reporting of abnormal results, adverse events, or other study required reporting.

Completes and corrects case report forms, ensuring accuracy of all records connected with each study with attention to medical events and concomitant medications as well as documentation for each study related event.

Acts as a liaison between study sponsors and investigators. Maintains accurate recording of all study test articles. Maintains complete and accurate documented studies in binders. Maintains knowledge of all research efforts conducted including those protocols or studies assigned to other coordinators.

Works with KUMCRI and other departments to construct the study package to include budget, approved protocol, procedures, discounts, billing, study contracts and other related documents and workflows.

Maintains current KUMCRI-required education, i.e., Human Subjects Protection, HIPAA. Adheres to GCP guidelines.

Promotes marketing, in accordance with HSC rules, and research protocols. Monitors awarded grants and contracts for compliance with performance, reporting, and accounting requirements.

Attends all staff meetings as well as meetings both onsite and off-site as required by study.

Serves as mentor for new staff members.

Other duties as assigned.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.

Required Qualifications

Education:

Bachelor’s degree in basic science or related field. Education may be substituted for experience on a year for year basis. Experience used to substitute education is in addition to any required work experience.

License:

Must have a current Kansas RN license upon hire and throughout duration of employment.

Work Experience:

2 years prior research or related experience.

Experience with regulations governing clinical research (CFR, GCP, HIPAA).

Experience with study budgets, contracts and grant applications.

Presentation experience.

Preferred Qualifications

Education:

Master's degree, experience in clinical research preferably in Cardiology trials.

Work Experience:

Cardiovascular research experience.

3 years of research experience.

Experience using medical terminology.

Skills:

Detail oriented.

Interpersonal communication skills.

Organizational and communication skills.