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University of Colorado Anschutz Medical Campus

Clinical Research Coordinator (Open Rank: Entry -Senior)
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Position Number: 5949724
Location: Aurora, CO
Position Type: Medicine - Other Medicine

Clinical Research Coordinator (Open Rank: Entry -Senior)

Clinical Research Coordinator (Open Rank: Entry -Senior) - 35985 University Staff Description

University of Colorado Anschutz Medical Campus

Department: Otolaryngology

Job Title: Clinical Research Coordinator (Open Rank: Entry -Senior)

Position 00831307- Requisition #:35985

Job Summary:

The School of Medicine's Department of Otolaryngology- Head and Neck Surgery has an opening for a full-time Research Services Clinical Sciences Professional (Clinical Research Coordinator, Open Rank, Dr. Santos-Cortez Lab).

This Clinical Science Professional will be assisting with human subject research at the laboratory of Principal Investigator (PI) Dr. Regie Santos-Cortez, which involves research for various otolaryngologic diseases such as hearing loss, otitis media, balance disorders and obstructive sleep apnea/sleep-disordered breathing. The work involves regulatory compliance, patient/subject recruitment and enrollment, data management and collection, and some manuscript writing/editing. The working environment is highly collaborative with close working relationships with various basic and clinical research groups on campus, nationally and internationally.

Jobs in the Research Services career family provide direct professional support of research activities. Functions include regulatory compliance, human subject compliance, research laboratory coordination and instruction, and environmental health and safety, among others.

Key Responsibilities / Duties

All levels:

Assist with and oversee the day-to-day operations of human subjects recruitment and sample collection
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 research
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 studies. Educate potential subjects on the details of the studies through phone contacts and personal interviews
Schedule subject participation in research, 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 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
Act as a Primary Clinical Research Coordinator on multiple studies
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
As team expands, assist and train junior team members in human subjects recruitment and sample collection

Additional Examples of Work Performed

General Study Duties

Coordinate departmental process for securing Institutional Review Board (IRB) approval
Assist faculty with development and writing of research protocols
Write informed consents/assents following IRB requirements
Submit application and applicable documents (protocol, informed consent, etc.) to overseeing IRB
Conduct literature search and reviews
Perform study-related duties per the research protocol. This may include, but is not limited to the following:
Interact with patients to gather study data and/or specimens
Extract data from patient charts (EPIC)
Perform other duties as delegated by the PI
Update research study tracking system as studies progress
Maintain required approvals throughout the course of each study

Data Management and Manuscript Preparation

Create/maintain research databases in REDCap, Excel, and OnCore
Enter data in various formats including sponsor specific Electronic Data Capture (EDC) for clinical trials
Track subject participation within a study
Assist with data analysis
Assist in preparation of abstracts, conference presentations, and manuscripts (within a limited capacity)

Compliance

Assure adherence to all research standards as set forth by The Office for Human Research Protections (OHRP), University of Colorado Health (UCH), Children's Hospital Colorado (CHCO), University of Colorado Denver (UCD), and other pertinent regulatory agencies
- Create and/or maintain Regulatory Binders and Subject Files
- Maintain compliance documentation based on research regulations, COMIRB requirements, and departmental Standard Operating Procedures (SOPs)

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 PI.

Work Location:

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

Why Join Us:

The University of Colorado Anschutz Medical Campus is a comprehensive urban research university offering more graduate and professional degrees than any other Colorado public institution. With our solid academic reputation, award-winning faculty and renowned researchers, the University of Colorado Anschutz Medical Campus is well known for its distinctive and highly productive research programs, its world-class health facilities at the Anschutz Medical Campus and its well-established partnerships in business, industry and government. This campus currently has over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at our Anschutz Medical Campus, a significant number of health care facilities are present throughout the Metropolitan Denver and front range of the State of Colorado, throughout which over 500 advanced practice providers currently practice.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of your gross pay
Paid Time Off: Accruals over the year
Vacation Days: 22/year (maximum accrual 352 hours)
Sick Days: 15/year (unlimited maximum accrual)
Holiday Days: 10/year
Tuition Benefit: Employees have access to this benefit on all CU campuses
ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

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, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

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:

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:

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) years of clinical research or related experience
Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
Ability to speak Spanish

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

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: Carly Moses, carly.moses@cuanschutz.edu

Screening of Applications Begins:

Screening begins Immediately and continues until position is filled. For best consideration, February 28, 2025.

Anticipated Pay Range:

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

Entry level: $47,743 - $60,729

Intermediate level: $51,956 - $66,088

Senior level: $56,169 - $71,447

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.
Application Materials Required: Cover Letter, Resume/CV, List of References Job Category
: Research Services Primary Location
: Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20264 - SOM-OTO GENERAL OPERATIONS Schedule
: Full-time Posting Date
: Jan 22, 2025 Unposting Date
: Ongoing Posting Contact Name: Carly Moses Posting Contact Email: carly.moses@cuanschutz.edu Position Number: 00831307

To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=35985&lang=en