University of Colorado Senior Professional Research Assistant in Aurora, Colorado
University of Colorado – Colorado Clinical and Translational Sciences Institute
Senior Professional Research Assistant
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.
The full time Clinical Research Monitor will be a key member of the Clinical Research Support Team (CReST). CReST is part of Colorado Clinical and Translational Sciences Institute, which aims to translate basic science knowledge into clinically useful treatment for patients. 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 developing a clinical monitoring program and providing direct monitoring services for investigator-initiated studies, particularly those studies where the local researcher is the sponsor/IND holder. This position will also act in a study coordinator role to support the work load of the CReST team.
Examples of Work Performed:
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 capture
Relays timely information to PI’s, study staff, and CReST
Provides Regulatory support for clinical trials, including submissions to institutional groups, IRBs and FDA.
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 and Benefits:
The hiring salary for this position is $55,000 to $85,000 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 at http://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: https://www1.ucdenver.edu/offices/human-resources/employee-relations-performance/ada-compliance
Office of Equity: https://www1.ucdenver.edu/offices/equity
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.
Masters of Science or equivalent degree
One year of experience as a monitor for human subjects research
Two years of clinical research experience, including regulatory support or as a clinical coordinator
Applicants must meet minimum qualifications at the time of hire.
Epic EMR experience
2 years monitoring clinical research studies, specifically Phase I and II studies
Experience drafting SOP and policy documents, especially those relating to clinical research monitoring activities
Experience creating and managing IRB submissions
Bi-lingual (Spanish & English)
Competencies / Knowledge, Skills and Abilities:
Proficiency in all Microsoft Office applications (Word, Excel, Outlook, PowerPoint)
Superior communication and organizational skills
Ability to work independently following training
Primary Location: Aurora
Job Category Faculty
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Sep 30, 2020
Unposting Date Ongoing
Posting Number 00764642
Req ID: 19291
The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.