Clinical Research Coordinator
University of Colorado - School of Medicine
Otolaryngology Clinical Research Coordinator
(Professional Research Assistant)
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, multiple clinical trials at multiple hospitals, and 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, performing study-related duties, 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, regulations, and departmental standard operating procedures.
Clinical Research Supervisor and Faculty Principal Investigators (PIs)
This role will receive supervision from multiple individuals.
Must be able to work independently.
Examples of Work Performed:
Responsibilities include, but are not limited to:
PI Initiated Studies
- Coordinates departmental process for Institutional Review Board (IRB) applications
- Assists faculty with development and writing of research protocols
- Writes informed consents/assents following IRB requirements
- Submits application and applicable documents (protocol, informed consent, etc.) to overseeing Institutional Review Board (IRB)
- Conducts literature search and reviews
- Performs necessary ongoing maintenance and/or study close-out duties
- Performs effective, efficient, and regulatory-compliant clinical trials
- Performs study-related duties per the research protocol. This may include, but is not limited to the following:
- Obtain Informed Consent
- Scheduling participants
- Interact with patients to gather study data
- Extract data from patient charts (EPIC)
- Perform other duties as delegated by the PI
Data Management and Manuscript Preparation:
- Create/maintain research databases in REDCap, Excel, and OnCore
- Enter data in various formats including sponsor specific EDC or CRF data queries 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
- Assures 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 Hospital (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
- Excellent interpersonal communication, organizational skills, ability to problem solve & 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
- Develops knowledge of Good Clinical Practices, FDA Rules and Regulations, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical research
- Develops 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 study regulations and billing processes
- Knowledge of basic human anatomy, physiology, and medical terminology.
- 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.
- Bachelor's degree from an accredited college or university
- 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
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:
Applications are accepted electronically at CU Careers, refer to requisition ID: 11090
When applying, applicants must include:
- A letter of application which specifically addresses the job requirements and outlines qualifications
- A current Resume/CV
- 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 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
Posting Date: Sep 13, 2017
Closing Date: Ongoing
Posting Contact Name: Kristi Engle Folchert
Posting Contact Email: email@example.com
Position Number: 00726646