University of Colorado – School of Medicine
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 Division of Cardiology is seeking applicants for a full-time Professional Research Assistant (PRA) position for the Cardiology Clinical Trials Program (CCTP)
This position is for a clinical trial data coordinator in the areas of interventional cardiology and imaging research, electrophysiology and heart failure. This position will support multiple Industry Supported Clinical Trials, Federally Funded Clinical Trials, and Investigator Initiated Clinical Trials. This position focuses primarily on the responsibility of data collection, interpretation and documentation of clinical research data, and meeting with research patients for study related purposes. The amount of time spent on required tasks may shift depending on the needs of the department.
Responsibilities include (but not limited to):
Abstracts and records all patient data essential to the study onto required Case Report Forms (CRFs) and into the Clinical Trials database, as needed, in an accurate and timely fashion.
Ensures complete source documentation is compiled in research records.
Assists clinical research coordinator(s) (CRC) in assessing patient eligibility for approved study by:
o Gathering source documents.
o Ensuring the current version of consent forms are completed, informed consent process in properly documented and filed.
o Reviewing medical history to determine eligibility status.
Collaborates with clinical research coordinator in obtaining grading levels for toxicities including assessment of clinical significance of all lab and test results and relatedness of adverse reactions to study product according to protocol guidelines.
Schedules and tracks submission of prescreening, screening and enrollment logs as required by study sponsor
Schedules, coordinates, prepares for and conducts sponsor monitor visits and audits in collaboration with the regulatory team, CRC and other research team members.
Meets with monitors to respond to any question of data validity and corrects/revises data as appropriate; answers queries from sponsoring companies.
Conducts follow-up of study patients
Obtains and reviews the electronic medical records via EPIC for the identifying and screening of potential research subjects;
Documents and maintains study records of research subjects including; laboratory test results, all clinical and study procedures as well as standard of care visits as required per the study protocol.
Recruits clinical study participants; coordinating and scheduling research appointments, interviews and evaluates potential participants, and develop and maintains accurate documentation of the progress of the research.
Conduct study assessment as required per the study protocol.
Documenting research notes into the EMR of participants.
Provides assistance to the PI, and Divisional Clinical Trials Manager.
Develops and submits accurate IRB applications, Continuing Review Reports and all other required documents to support the conduct of clinical trials research.
Any other tasks, as assigned by the supervisor.
Bachelor of Science
Work experience in areas of clinical research
A minimum of two years full-time research experience in most of the areas mentioned.
Knowledge, Skills & Abilities:
Must have detailed knowledge of Good Clinical Practice (GCP) /ICH guidelines in clinical research.
Excellent communication and organizational skills
Attention to detail
Ability to work independently in a fast-paced clinical trials program
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 atEmployee 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 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.
Total Compensation Calculator:https://www.cu.edu/employee-services/total-compensation
Diversity and Equity:
Please click here for information on disability accommodations:http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx
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.
Organization: *H0001 -- Anschutz Medical Campus
Title: Professional Research Assistant
Requisition ID: 15193