- Assist with and oversee the day to day operations of clinical trials and studies
- Collect, code, and analyze data obtained from research in an accurate and timely manner
- Assist and train junior team members
- Adhere to research regulatory standards
- Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines
- Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
- Assist with identifying issues related to operational efficiency and shares results with leadership
- Act as a Subject Matter Expert and authority in the area of nursing
- Act as a Primary Coordinator on multiple trials/studies
- Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
- Ensure that the necessary supplies and equipment for studies are in stock and in working order
- Interview prospective subjects for a variety of research clinical trials. Educate potential subjects on the details of the studies through phone contacts and personal interviews
- Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required
- Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria, and confirms eligibility of subject to participate in clinical trial
- Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
- Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
- Coordinate and administer patient care in compliance with protocol requirements
- Disburse investigation drug and provide patient education regarding administration
- Oversee the preparation of orders by physicians to assure that protocol compliance is maintained.
- Independently review patients for changes in condition, adverse events, concomitant medication use, protocol compliance, response to study drug and thoroughly document and report all findings to physician and care team
- Assist with developing protocol-specific systems and documents including process flows, and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
- Serve as a resource and participate in study initiation and close out duties
- Sample processing and shipment
- Three (3) years of clinical research or related experience
- Bachelor of Science in Nursing (BSN) degree
- An Associate Degree in Nursing (ADN) degree and two (2) additional years of experience will substitute for the BSN degree
- Current licensure as a registered nurse
- Experience with IV placement
- Experience administering medications via IV infusion, IM/SQ injection
- Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
- Knowledge and understanding of federal regulations and Good Clinical Practice (GCP)
- Ability to communicate effectively, both in writing and orally
- Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
- Outstanding customer service skills
- Demonstrated commitment and leadership ability to advance diversity and inclusion
- Knowledge of basic human anatomy, physiology medical terminology
- Ability to interpret and master complex research protocol information
- Expert level knowledge of nursing process, function and/or technology
- A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
- Curriculum vitae / Resume
- Three to five professional references including name, address, phone number (mobile number if appropriate), and email address
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clinical research nurse - Aurora, CO , USA, United States - University of Colorado
Description
University of Colorado Anschutz Medical CampusDepartment:
Barbara Davis Center
Job Title:
Clinical Research Nurse
Position # Requisition #32802
Job Summary:
The Barbara Davis Center (BDC) for Childhood Diabetes at the University of Colorado Denver is a multi-disciplinary diabetes center affiliated with the University of Colorado, School of Medicine.
The BDC also serves as a clinical center for TrialNet, an international, multi-center research organization with the goal of understanding the pathophysiology of type 1 diabetes as well as finding ways to prevent type 1 diabetes.
Additionally we have many treatment and prevention industry sponsored clinical trials for type 1 diabetes.The Prevention Team at the Barbara Davis Center is seeking a full-time Principal Professional Clinical Research Nurse (RN). The Prevention Teams conducts clinical trials for type 1 diabetes prevention and intervention. This position involves coordinating and running clinical trials in type 1 diabetes both NIH funded and independently funded.
The person in this position will act as the lead study coordinator on one or more clinical trials and provide support on numerous other trials.
Principal Professional Clinical Research Nurses provide direct professional support of research activities. This includes sponsor communication, and human subject compliance.Principal Professionals are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions.
Work involves creating, integrating, applying and sharing knowledge directly related to a professional field. Work is performed at an advanced or expert level.Key Responsibilities:
Work Location:
Onsite - this role is expected to work onsite and is located in Aurora, Colorado.
Why Join Us:
The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more.
To see what benefits are available, please visit:
Diversity and Equity:
The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty, and administrative staff.
Qualifications:
Minimum
Qualifications:
Preferred
Qualifications:
Knowledge, Skills, and Abilities:
How to Apply:
For full consideration, please submit the following document(s):
Questions should be directed to:
Danielle Schlosser,
Screening of Applications Begins:
Applications will be accepted until finalists are identified, but preference will be given to complete applications received by May 1, 2024.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established as $64,594- $75,575.
The above hiring range represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
Total Compensation Calculator:
ADA Statement:
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at
Background Check Statement:
The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students, and visitors.
Vaccination Statement:
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases.
If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively.
In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.
