Clinical Research Monitor

Description

UNIVERSITY OF COLORADO DENVER | ANSCHUTZ MEDICAL CAMPUS

Office of the Vice Chancellor for Research – Clinical Research Support Team (CReST)

Clinical Research Monitor (Senior PRA)

Position #00796344 – Requisition #25889

* 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.

Nature of Work

The full time Clinical Research Monitor will be a key member of the Clinical Research Support Team (CReST). CReST is part of the Office of the Vice Chancellor for Research.  CReST provides support to investigators for all activities related to the successful conduct of clinical research, from study start-up through close out, under a fee for service model.  This position will focus on clinical monitoring and providing direct monitoring services for investigator-initiated studies, particularly those studies where the local researcher is the sponsor/IND holder. This position may also act in a clinical research coordinator role to support the work load of the CReST team.

Examples of Work Performed

The duties and responsibilities of the position include, but are not limited to:

    Monitors data compliance, reporting findings to the study’s principal investigator (PI). Ensures quality of study data through identification, evaluation and resolution of discrepancies and other efforts to reduce data errors by researchers.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, University of Colorado Denver (UCD), and other pertinent regulatory agencies.Assists research teams to develop appropriate monitoring plans based on the complexity of the study. Assist with the development of eCRFs or appropriate database resources for data captureRelays timely information to PI’s, study staff, and CReST Provides Regulatory support for clinical trials, including submissions to institutional groups, IRBs and FDA.When needed, serve functions as a clinical research coordinator for industry, federal or locally funded clinical studies, including:Conducting the informed consent process, and ensuring proper documentation.Reviewing protocol inclusion/exclusion criteria to confirm study eligibility. Recruiting prospective participants and conducting data collection visits for multiple clinical studies.  Contacting potential participants with the details of the study via phone and in-person interviews. Working with the manager to coordinate scheduling of participant and monitoring visits.Recognizing adverse events and prompt notification of appropriate parties.Other duties as assigned by manager 
 

Salary Range

The hiring salary for this position is $55,000 to $75,000 commensurate with skills and experience.  

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.

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 [email protected].

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, persons within the LGBTQ+ community, 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
Minimum Qualifications  

Applicants must meet minimum qualifications at the time of hire.

    Masters degree from an accredited universityThree years of clinical research experience, including regulatory support or as a clinical coordinator or clinical data coordinatorSubstitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis. 
Preferred Qualifications

    Epic EMR experience1+ years monitoring clinical research studies, specifically Phase I and II studiesClinical research experience in Oncology and/or Cellular TherapiesExperience drafting SOP and policy documents, especially those relating to clinical research monitoring activitiesExperience creating and managing IRB submissionsBi-lingual (Spanish & English)
Knowledge, Skills, and Abilities

To be successful in this position, candidates will need the following:

    Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)Excellent writing skillsData management Superior communication and organizational skillsAbility to work independently following trainingStrong attention to detailWillingness to learn new skills, as neededAbility to work in a fast-paced environment


Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: May 5, 2022
Unposting Date: Ongoing

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