Clinical Research Services Entry-Principal Professional

Job Summary:

The Adult Division at the Barbara Davis Center (BDC) has a robust clinical and research program designed to improve health conditions in adults living with Type 1 Diabetes.  Research is conducted on new advanced diabetes technology, outcomes related to use of technology, and the health complications related to T1D.  Within the Adult Division is the Pregnancy and Women’s Health Clinic, which helps women manage glucose fluctuations across menstrual cycles, pregnancy, and through the menopausal transition. There is a robust clinical and research program in the Pregnancy and Women’s Health Clinic designed to improve health conditions in women living with diabetes and conduct research on advanced diabetes technology use in pregnancy, recognizing long-term complications from diabetic pregnancies, and following offspring of pregnant women for the onset of diabetes in their children. The successful candidate will actively participate in facilitating patient-oriented research projects conducted by BDC investigators.  Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research.

Key Responsibilities:

Entry – Principal Level

• 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 ensure 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
• Schedule subject participation in research clinical trial, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy)
• Assist investigator to create databanks such as in Excel, REDCap, or other relevant software programs

Intermediate – Principal Level

• 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

Sr. Professional – Principal Level

• 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 Level

• Oversee and provide informal leadership to the team members, including managing day-to-day priorities, evaluating and redistributing workloads on a temporary basis, and mentoring staff
• Provide input and feedback to leadership on team members’ overall performance, performance evaluations, opportunities for development, and process improvement initiatives
• Identify training and development opportunities for new and existing team members

Work Location:

Onsite – this role is expected to work onsite and is located in Aurora, CO. 

Why Join Us:

The Barbara Davis Center for Diabetes is one of the leading centers in the nation for clinical care and research in the area of type 1 diabetes.  We are on the forefront of research involving the use of diabetes technologies, including continuous glucose monitoring and automated insulin delivery devices.  We have a robust research portfolio and our center works with many of the other major diabetes research centers in the country and the world on multi-center studies.

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:

Entry – Principal Level

• 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

Additional Qualifications - Intermediate Level

• One (1) year clinical research or related experience

Additional Qualifications - Senior Level

• Two (2) years clinical research or related experience

Additional Qualifications - Principal Level

• Three (3) years clinical research or relate experience 

Preferred Qualifications

Entry – Principal Level

• Bachelor’s degree in science or health related field
• Clinical research or related experience
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)

Intermediate Level

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

Senior Level

• Three (3) years of clinical research or related experience

Principal Level

• Four (4) years of clinical research or related experience

Knowledge, Skills, and Abilities

• Knowledge and understanding of federal regulations and Good Clinical Practice (GCP) (Advanced knowledge at Principal Level)
• 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
• Principal Level: Expert level knowledge of clinical research process, function and technology

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: [email protected]  

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by 3/18/2024. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

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

Entry Level: $47,084 - $59,891

Intermediate Level: $51,239 - $65,176

Senior Level: $55,393 - $70,460

Principal Level: $63,702 - $81,029

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 [email protected] ​.

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 .