Job Details

University of Colorado Anschutz Medical Campus

Clinical Sciences Professional (Open Rank)- Pediatric Endocrinology Research
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Position Number: 5608821
Location: Aurora, CO
Position Type: Medicine - Physicians

Clinical Sciences Professional (Open Rank)- Pediatric Endocrinology Research - 26334 University Staff

Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine | Department of Pediatrics | Section of Endocrinology

Official Title: Research Services Clinical Sciences Professional (Open Rank)

Working Title: Clinical Sciences Professional (Open Rank)

Position #00798103 – Requisition #26334

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date. Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Denver: https://www.ucdenver.edu/coronavirus

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

Anschutz Campus – Exemptions are allowed for medical or religious reasons.
Denver Campus - Exemptions are allowed for medical, religious, or personal reasons.
Consolidated/Central Services Administration – Will follow Anschutz policy on exemptions.

The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

The University of Colorado Anschutz Medical Campus is a world-class medical destination at the forefront of transformative science, medicine, education and patient care. The campus encompasses the University of Colorado health professional schools, more than 60 centers and institutes, and two nationally ranked independent hospitals - UCHealth University of Colorado Hospital and Children's Hospital Colorado - that treat more than two million adult and pediatric patients each year. Innovative, interconnected and highly collaborative, the University of Colorado Anschutz Medical Campus delivers life-changing treatments, patient care and professional training and conducts world-renowned research fueled by over $650 million in research grants. For more information, visit www.cuanschutz.edu.

The School of Medicine's Department of Pediatrics, Section Endocrinology has an opening for a full-time University Staff (unclassified) Research Services Clinical Science Professional (Open Rank) position.

Jobs in the Research Services career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.

Professionals at all levels 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.

At the intermediate level, duties are less limited in scope and are performed independently with occasional guidance and direction from other professionals. At the senior level, work is performed fully independently.

Nature of Work

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 development of new technologies. Clinical Science Professionals may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Some Assignments will not move beyond this level.

This position will coordinate clinical research studies for the Depression and Insulin Sensitivity in Adolescents study and the Mindfulness-Based Intervention for Depression and Insulin Resistance in Adolescents at Risk for Type 2 Diabetes study at Children's Hospital Colorado.

This is a full-time (40 hours per week) position with duties involving the coordination of single and multisite studies designed to evaluate behavioral interventions for depression and type 2 diabetes prevention in adolescents. Funding is guaranteed for one year with possibility for extension beyond this period. This position involves participant recruitment, facilitating study visits, data management, development and oversight of multisite protocols, regulatory affairs, and excellent interpersonal skills with both colleagues and patient families. The ideal candidate will be self-directed, adaptable, and have enthusiasm for pediatric research, adolescents, and medical/health psychology.

Examples of Duties Performed

Intermediate 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 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 Level, all of the above and:

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

Additional Duties and Responsibilities

All Levels:

Complete and submit IRB applications, amendments, and continuing reviews
Create and maintain study regulatory documents, including regulatory binder and manual of operating procedures, and create/modify study standard operating procedures
Build data collection tools in REDCap
Maintain comprehensive knowledge of relevant study protocols
Train and onboard study personnel at other sites and ensure regulatory compliance
Communicate with study personnel at other sites, including phone, email, and video conferencing
Conduct site audits and data quality control across multiple enrollment sites
Help prepare study progress summaries for sponsors, independent site monitor for clinical trials, and independent monitoring committee
Basic descriptive data analytics
Excellent and prompt communication with both parents/participants and study team

This description is a summary only and is describing 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.

Minimum Qualifications

Entry:

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

Intermediate 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
One (1) year clinical research or related experience

Senior 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
Two (2) years clinical research or related experience

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications

All Levels:

Bachelor's degree in science or health related field
Two (2) to three (3) years of clinical research or related experience
Experience working with REDCap, Epic, and/or statistical software
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
Experience with pediatric research and/or psychology/neuroscience
Experience with multisite clinical trials
Oral and written fluency in English and Spanish

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
Exceptional interpersonal skills
Ability to multitask
Excellent time management and organizational skills
Ability to work independently and as part of a team
Ability and willingness to work with adolescents with obesity, depression, and prediabetes

Salary and Benefits

The salary range (or hiring range) for this position has been established at the following:

Entry Level: $44,403-$56,481

Intermediate Level: $48,321-$61,464

Senior Level: $52,239-$66,448

The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.

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 is not eligible for overtime compensation.

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.

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

Total Compensation Calculator: http://www.cu.edu/node/153125

Diversity and Equity

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@ucdenver.edu.

The University of Colorado Denver | 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 and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

The University of Colorado Denver | 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.

Qualifications
Special Instructions to Applicants: Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references) Application Materials Required: Cover Letter, Resume/CV, List of References Application Materials Instructions: Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Review of applications will begin immediately and will continue until the position is filled.

Job Category: Research Services

Primary Location: Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20971 - SOM-PEDS Endocrinology-GenOps

Schedule: Full-time

Posting Date: Nov 11, 2022

Unposting Date: Ongoing Posting Contact Name: Lauren Shomaker Posting Contact Email: lauren.shomaker@childrenscolorado.org Position Number: 00798103