Clinical Research Coordinator




University of Colorado - School of MedicineOtolaryngology Clinical Research Coordinator

(Professional Research Assistant)

Position: 00050235

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:
    • Interact with patients to conduct informed consent process
    • Scheduling participants
    • 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
  • 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
    • Create and/or maintain Regulatory Binders and Subject Files
    • Maintain compliance documentation based on research regulations, COMIRB requirements, and departmental Standard Operating Procedures (SOPs).



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)

Salary and Benefits:



Salary is commensurate with skills and experience. The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.

The University of Colorado Denver 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.

The University of Colorado strongly supports the principle of diversity. 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 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.


Qualifications

Minimum Requirements
  • Bachelor's degree from an accredited college or university


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



Application Materials Required:Cover Letter, Resume/CV, List of References

Application Materials Instructions:

Applications are accepted electronically at CU Careers, refer to requisition ID: 12456

When applying, applicants must include:
  1. A letter of application which specifically addresses the job requirements and outlines qualifications
  2. A current Resume/CV
  3. The names, addresses, daytime telephone numbers and e-mail addresses for three professional references, either attached to your resume/CV or uploaded as a separate document
Please be advised that the University does check references as part of the employment process.

Please do not submit any of your application material (via email) to the job posting contact.



Job Category: Faculty

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 20264 - SOM-Otolaryngology

Schedule: Full-time

Posting Date: Jan 24, 2018

Closing Date: Ongoing

Posting Contact Name: Chris Brands

Posting Contact Email: chris.brands@ucdenver.edu

Position Number: 00050235

PI101379418

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