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University of Colorado Professional Research Assistant - Clinical Research Coordinator in Aurora, Colorado

University of Colorado Anschutz Medical Campus

Otolaryngology Clinical Research Coordinator

Professional Research Assistant (PRA)

Position: 00766804

The University of Colorado Denver l 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.

_Nature of Work_

The Department of Otolaryngology is seeking a Professional Research Assistant (working title of Clinical Research Coordinator, or CRC) responsible for guiding and assisting the Department’s faculty in clinical research studies. The Coordinator must understand and navigate the complexities of a multifaceted academic medical center, the governances of clinical trials and the responsibilities of PI-Initiated studies in order to successfully perform a variety of clinical research responsibilities.

Working under the direction and guidance of the Clinical Research Supervisor, the Coordinator has responsibility for assisting faculty in developing new studies, managing the review process of oversight committees, interacting with patients throughout the course of the study, and working with the finance team regarding proper hospital payments to assure proper funds flow. The Coordinator is also responsible for guiding faculty compliance with protocols, federal and local regulations, and departmental standard operating procedures.

_Professional Field_

Clinical Research

_Supervision Received_

Clinical Research Supervisor and Faculty Principal Investigators (PIs).

This role will receive supervision from multiple individuals.

Must be able to work independently.

_Supervision Exercised_

No staff supervision

_Examples of Work Performed_

Responsibilities include, but are not limited to:

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 Institutional Review Board (IRB)

  • Conduct literature search and reviews

  • Perform study-related duties per the research protocol. This may include, but is not limited to the following:

o Interact with patients to conduct informed consent process

o Scheduling participants

o Interact with patients to gather study data and/or specimens

o Extract data from patient charts (EPIC)

o 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

  • Operate at the highest ethical and compliant levels required for healthcare and research

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 study

  • Assist with data analysis

  • Understand basic statistical analysis on study data and/or collaborate with statisticians

  • Assist PI’s, fellows, and residents prepare abstracts, conference presentations, and manuscripts

  • Submit manuscripts to medical journals

  • Help revise manuscripts to address journal reviewers’ comments and critiques, if applicable

Compliance

  • Assure adherence to all research standards as set forth by the Food and Drug Administration (FDA), 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

o Create and/or maintain Regulatory Binders and Subject Files

o Maintain compliance documentation based on research regulations, COMIRB requirements, and departmental Standard Operating Procedures (SOPs)

_Salary and Benefits_

The hiring salary is commensurate with skills and experience. This position is not eligible for overtime compensation.

The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located athttps://www.cu.edu/employee-services.

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 checks for all new employees prior to their employment.

The Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.

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: https://www.cu.edu/employee-services/total-compensation

Diversity and Equity:**

Please click here for information on disability accommodations:http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx

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.

_Knowledge, Skills, and Abilities_

Character

  • Excellent interpersonal communication, organizational skills, ability to problem solve and multi-task

  • Ability to coordinate multiple projects and meet project and study timelines

  • Flexibility and ability to adapt to various situations

  • Possess a level of comfort working with patients and clinicians

  • Ability to work independently within a team environment

Clinical Research Knowledge

  • Willingness to develop knowledge of Good Clinical Practices, FDA Rules and Regulations, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical research

  • Willingness to develop knowledge of University of Colorado Denver, UCH, and CHCO Policy and Procedures in relation to conducting multiple clinical research trials.

  • Develops a working knowledge of hospital billing processes

General

  • Knowledge of basic human anatomy, physiology, and medical terminology

  • Extensive experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook)

_Minimum Requirements_

  • Bachelor’s degree from an accredited college or university prior to first day of employment

_Preferred Qualifications_

  • Minimum of 1 year clinical research experience

  • Experience with PI initiated studies

  • Experience submitting to the Institutional Review Board

  • Experience with data management

  • Experience with statistical analysis

  • Certification of CITI Biomedical Research (Group 1), Health Information Privacy and Security (HIPS), and Good Clinical Practices (GCP) Trainings or willingness to complete prior to beginning employment

Job: *Faculty

Organization: *U0001 -- DENVER & ANSCHUTZ MED CAMPUS

Title: Professional Research Assistant - Clinical Research Coordinator

Location: Aurora

Requisition ID: 17084

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