Job Summary:

The Department of Orthopedics, Spine Division at the University of Colorado Denver l Anschutz Medical Campus is seeking a Professional Research Assistant (PRA) with significant clinical research experience to interact with patients during study visits and ensure completion of all necessary documentation, as well as facilitate study-related billing and subject travel reimbursement. The PRA will serve as a liaison to study sponsors and will lead site visits and facilitate regular monitor visits with sponsor representatives. This position will assist faculty with all aspects of administrative activities related to the submission of Institutional Review Board (IRB) protocols to the Colorado Multiple Institutional Review Board (COMIRB), Western IRB (WIRB), and other regulatory agencies. This includes protocol development, writing consent forms, protocol deviation, adverse event and serious adverse event reporting, and managing continuing reviews and amendments of protocols. The PRA will ensure compliance with all internal and external policies and procedures that govern the department's human subject's research and includes the development of and compliance with departmental standard operating procedures for the research. This also includes monitoring FDA-IDE and IND trials. The PRA will also assist in the development and maintenance of a record keeping system of protocols for COMIRB and other regulatory agency activities. The PRA will work closely with the research manager to ensure compliance in conductance of the research.

Key Responsibilities:

• Review medical records to screen for new participants in enrolling studies.
• Monitor on-going research projects on a daily basis, including daily review of the clinic schedule for any self-scheduled research patients.
• Track and schedule upcoming patient study visits in compliance with visit schedules per protocol.
• Ensure compliant conductance of the consent process. Forward signed consent forms to the appropriate institutional entity for archiving.
• Communicate with providers regarding required clinical data and imaging for study visits.
• Interact with patients during study visits and ensure that all study related data is collected, including clinical data and required imaging, and recorded on the CRF.
• Maintain study participant binders per FDA ALCOA guidelines.

Why Join Us:

We are committed to providing the highest quality, professional, and ethical care for all our patients through the integration of comprehensive education and exceptional musculoskeletal research. We are dedicated to educating the next generation of orthopedic surgeons, and changing the landscape of our field with breakthrough discoveries in new treatment options and groundbreaking research.

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: https://www.cu.edu/employee-services/benefits-wellness.

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications

• Bachelor's degree in any field
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis

Preferred Qualifications

• Bachelor's degree in science or health related field
• Master's degree in health related field
• Clinical research or related experience
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Excellent knowledge regarding IRB policies and procedures
• Excellent knowledge regarding Sponsor and FDA regulatory requirements

Competencies, Knowledge, Skills, and Abilities

• 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

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
2. Curriculum vitae / Resume
3. Three to five professional references including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Thomas Roller, THOMAS.ROLLER@CUANSCHUTZ.EDU

Screening of Applications Begins:

Screening begins one week from posting and continues until position is filled.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as

$47,743 - $60,729

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

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: http://www.cu.edu/node/153125

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 hr.adacoordinator@cuanschutz.edu.

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. To assist in achieving that goal, we conduct background investigations for all prospective employees.

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.