Research Services Senior - Principal Professional (Research Services Professional, Clinical Sciences) Open Rank

Job Summary:

The Injury Generated by Burn and Frostbite (IGNITE) lab in the Department of Emergency Medicine has an opening for a full-time University Staff (unclassified) Research Services Senior- Principal Professional position.

IGNITE conducts clinical research, focusing on clinical trials in the acute care setting with a particular focus on early interventions for critically injured burn and frostbite patients. IGNITE receives significant funding from the Department of Defense.

The University of Colorado Denver | Anschutz Medical Campus| Department of Emergency Medicine, is currently seeking applications for a Research Services Open Rank (Senior to Principal) Professional. This is a full-time, University Staff (non-classified) position, for the IGNITE lab.

The Department of Emergency Medicine and IGNITE lab seeks motivated applicants for the position of Clinical Science Professional. This role will engage patients, families, and clinical staff at the University of Colorado Hospital, manage study start-up and documentation for clinical trials, collaborate with clinical and research teams working to improve care of critically injured burn and frostbite patients. The projects focus on patients in the Emergency Department and Burn Intensive Care Units with critically injured burn and frostbite patients. The ideal candidate will have experience within research (clinical or laboratory), collaborate effectively on multidisciplinary teams, and be highly detail oriented.

Professional Field

Clinical Sciences, Research

Supervision Received

This position will report directly to the ATLAS Principal Investigator and ATLAS Manger

Supervisory Authority

None

Key Responsibilities:

General Duties:

• Assist with and oversee the day-to-day operations of clinical trials and studies
• 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
• 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
• 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
• Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
• Collect, code, and analyze data obtained from research in an accurate and timely manner
• 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
• Participate in subject recruitment efforts, including communicating with patients expressing an interest and all pre-screening/screening activities
• Ensure that the necessary supplies and equipment for studies are in stock and in working order
• Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies
• Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies
• Assist Team Leads, Supervisors and/or management with creation and implementation of processes and procedures and quality improvement initiatives
• Act as a Primary Coordinator on multiple trials/studies
• Assist and train junior team members

Senior Professional and all the above:

• Assist with developing or develops protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs) and Case Report Forms (CRFs). Maintains subject level documentation and prepares documents, equipment and/or supplies
• Assist with identifying issues related to operational efficiency and shares results with leadership
• Collect information to determine feasibility, recruitment and retention strategies. Employ, evaluate and assist with the implementation of innovative solutions to maximize recruitment and retention
• Serve as a resource and participate in study initiation and close out duties

Principal professional and all the above:

• 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

Additional Duties & Responsibilities:

• Assist with budget creation and grant submissions
• DOD regulatory and technical reporting submissions
• Manage and conduct moderately complex research activities that are part of larger project from initiation to close.
• Create complex data management and tracking tools (REDCap, Excel) to support tracking of project/recruitment activities.
• Oversee student worker(s) or junior PRAs as it relates to a specific project.
• Participate in instrument creation (REDCap) and/or analytical structures as appropriate to the project.
• Collect study data via complex patient visits, surveys, observations or focus groups. Provide leadership in data collection to other PRAs and students.
• Participate in audits, monitoring visits, and quality control checks of data collection, equipment maintenance, and study procedures.
• Help develop study findings for presentation to team and external audiences.
• May lead publication development (abstract/manuscript)
• Help with budget management/tracking (under direction of PM/PI)
• Lead manuscript preparation for publication or presentation in scientific forums.
• Work with members of the UCD and UCHealth community as needed to set up labs, participant visits, and access shared University resources.
• Manage study participant incentive program with the assistance of procurement.

This description is a summary only and describes the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Work Location:

Hybrid - 4 days on-site, this role is expected to work onsite and is located in City, State.

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: 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:

Senior Professional:

• 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
  
  
  
  
• Two (2) years clinical research or related experience

Principal Professional:

• 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
    
    
    
    • Optional Substitution : Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.
    
    
    
    
  
  
  
  
• Three (3) years clinical research or relate experience

Preferred Qualifications:

• Four (4) 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
  
  
  
  
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Current licensure as a registered nurse

Required: Applicants must meet minimum qualifications at the time of hire.

Knowledge, Skills, and Abilities:

• Advanced 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

Screening of Applications Begins:

Immediately and continues until position is filled

Anticipated Pay Range:

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

Principal: $63,702 - $81,029

Senior: $55,393 - $70,460

The above 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.