Description

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.

  

Job Summary:

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.

 

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.

QualificationsMinimum Qualifications:

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 mustmeet minimum qualifications at the time of hire. 

Preferred Qualifications:

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)

Data management

Superior communication and organizational skills

Ability to work independently following training

Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: Sep 30, 2020
Unposting Date: Ongoing