Clinical Sciences Professional - Pregnancy Trials

Job Summary:

Nature of Work:

The College of Nursing in collaboration with the Division of Endocrinology, Maternal-Fetal Medicine is looking to hire a highly capable Clinical Sciences Professional to help execute NIH- and other institutionally funded studies in pregnant women and their infants. The current studies focus on how excess maternal lipids (triglycerides), in addition to glucose, can cause babies to be born with excess fat in their adipose tissue and their livers. The Clinical Sciences Professional would be part of a highly cohesive and exciting research team, Infant GOLD (Investigations in the Gestational Origins of Lifelong Development), that investigates the intrauterine origins of childhood metabolic disease (www.infantgoldresearch.org). The role involves recruitment, protocol consent, and conducting maternal/infant visits. In the current projects, the Clinical Sciences Professional will teach participants to test their blood triglycerides and glucoses by fingerstick using point-of-care devices. This Clinical Sciences Professional position requires strong organizational skills to schedule study visits and ensure appropriate follow-up. It involves working closely with the clinical team, pregnant participants, infants, and families across the Anschutz Medical Campus. The position also calls for coordination of sample collections and processing at clinical visits. The job occasionally involves being available at night or weekends when a participant delivers, and placenta and cord blood are necessary to collect. Applicants who are enthusiastic about working with pregnant participants and their infants and being a part of a research team who has been together for over 20 years conducting impactful studies in pregnancy are encouraged to apply.

Clinical Science Professionals perform clinical research-related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or the development of new technologies. Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research.

This Clinical Sciences Professional works on a variety of research projects, is on campus most days, and works with research participants in the clinical/hospital setting. 

Examples of Duties Performed

• Assist with and oversee the day-to-day operations of clinical trials and studies.
• Screen Medical records for potential participants including review of inclusion/exclusion criteria.
• Interview prospective research participants for a variety of clinical research trials. Educate potential participants on the details of the studies through phone contacts and personal interviews and confirm eligibility to participate.
• Perform the 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.
• Schedule subject study visits including, coordinating availability of necessary space, and clinical research support (e.g., physician, nurse practitioner, laboratory, radiology, pharmacy).
• Collect, code, and analyze data obtained for research in an accurate and timely manner.
• Teach pregnant participants how to use a triglyceride point-of-care meter and glucometer to measure their blood levels by fingerstick.
• Perform study procedures which include placement of continuous glucose monitors, obtaining anthropometric measurements, and processing and storage of blood and tissue samples.
• Coordinate postpartum visits and mother/infant visits which will contain procedures to measure infant fat mass and liver fat.
• On infrequent occasions and on a rotating basis, be available nights and/or weekends to coordinate collections of delivery samples including the placenta and cord blood at labor and delivery in Denver Metro Hospitals.
• Adhere to and maintain 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.
• 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.

Additional Examples of Work Performed:

• Maintain accurate and timely documentation of research and correspondence activities for assigned projects.
• Manage relevant software and database applications, including EPIC, REDCap, OnCore, etc. for assigned research projects.
• Provide support to assigned faculty and/or staff members related to grant writing, technical writing, poster support, etc.
• Be part of a highly connected and engaged Mom-Baby clinical research team. 

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 needs. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

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 Professional:

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

Intermediate Professional:

• Bachelor’s degree in any field.
  • Substitution : A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year-for-year basis.
• One (1) year of clinical research experience or related experience.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Bachelor’s degree in science or health related field.
• Two (2) years of clinical research or related experience.
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems such as RedCap and/or Atlas.ti).
• Experience in quantitative and/or qualitative research and relevant software.

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, and medical terminology.
• Ability to interpret and master complex research protocol information.
• Outstanding organizational skills and attention to detail.
• Ability to represent the University in a professional and positive manner.
• Ability to collaborate as a member of a team and to work highly independently to meet competing demands.
• Innovative problem-solving skills, and ability to thrive on challenges encountered in fluid, complex environment.
• Knowledge of institutional and governmental research administration policies and procedures and ability to strictly follow IRB, FDA, and HIPAA regulations.
• Proficient use of computer and relevant software and database applications, including REDCap, OnCore, and Microsoft Office, as well as the ability to master new software programs.
• Excellent project management, organizational, and time management skills.

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 April 12, 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 Professional - $47,743 to $60,729

Intermediate Professional - $51,956 to $66,088

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 .