University of Colorado Professional Research Assistant in Aurora, Colorado
University of Colorado – School of Medicine
Regulatory Affairs/Clinical Research Coordinator
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 Regulatory Affairs Coordinator is responsible for coordinating the regulatory aspect for a portfolio of clinical trials in the Department of Radiology (DOR). The position also acts as Clinical Research Coordinator for active sponsored and investigator initiated clinical trials. The position supports the Med Physics section with Equipment database and acts as a resource for services provided by the DOR to other entities on the Anschutz Medical Campus.
Some duties of this position may be:
Manage all new and existing IRB submissions for department sections.
Collaborate with hospital staff to ensure tests and procedures required by clinical protocols are scheduled and performed correctly.
Support the Medical Physics section in the Sharepoint database tracking of 300 pieces of equipment.
Recruit and interview prospective subjects for clinical trial studies in the Department of Radiology.
Familiarize potential subjects with the details of the study through phone contacts, personal interviews, and informed consent.
Schedule subject participation in research, coordinating all aspects of research requirements and physician support.
Assure compliance with protocol details, complete necessary records, and accurately transfer source documentation into Case Report Forms (CRFs). Maintain clinical research patient files and ensure compliance for records required for each study.
Update and maintain various databases, specific to each clinical trial. Recognize adverse and serious adverse events, and provide prompt notification to the appropriate parties.
Prepare documentation for monitoring visits and FDA audits.
Coordinate clinical trial initiation procedures including regulatory document submissions.
Manage regulatory binders and ensure proper documentation are filed appropriately.
Knowledge, Skills, and Abilities
Infectious Materials/Human Blood or Bodily Fluids
Radioactive Materials/Ionizing Radiation
HIPAA - Access to PHI
HIPAA - Operations
HIPAA - Payment
HIPAA - Research
HIPAA - Treatment
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 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.
A Bachelor’s degree and excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task.
Applicants must meet minimum qualifications at the time of hire.
Some Research Regulatory experience.
Experience in industry and/or PI initiated sponsored clinical research trials.
Knowledge of Good Clinical Practice guidelines and FDA regulations.
Ability to work on audits of clinical trials.
Experience in databases and data entry procedures
Knowledge of basic human anatomy, physiology, medical terminology, and
Ability to use MS Excel at an intermediate level.
HIPAA and human subjects’ certifications.
Experience working in the EPIC electronic medical record system
Experience working in the OnCore research management system
Primary Location: Aurora
Job Category Faculty
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Oct 30, 2020
Unposting Date Ongoing
Posting Contact Name Karen Kimes
Posting Contact Email email@example.com
Posting Number 00661121
Req ID: 19490
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.