University of Colorado – School of Medicine
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.
Nature of Work
The Professional Research Assistant (PRA) is a 100% FTE position within the Department of Medicine and Division of Rheumatology. This person will function as a Clinical Research Nurse focusing on systemic lupus erythematosus and rheumatoid arthritis at the University of Colorado Anschutz Medical Campus.
This position will be responsible for the overall organization and implementation of assigned study protocols/ clinical trials, including study start-up, subject recruitment, screening, consenting, and coordination of study procedures and data collection. This position will be responsible for managing the regulatory activities of the protocols, including submission and maintenance of documents for IRB, hospitals, and sponsors, as specified by the protocol and reporting requirements. They will serve as the liaison between sponsors, investigators and study subjects.
The vast majority of activities will be on the Anschutz Medical Campus, though there may be occasional requirements to visit other sites in the Denver metropolitan area. Additional travel for training on study protocols may be required by sponsoring organizations. Occasional evening or weekend hours may be required to accommodate the schedules of study subjects.
This position will report to Dr. Susan Boackle, Associate Professor of Medicine, and will work with collaborating investigators in the Division of Rheumatology.
This position will not have any supervisory responsibility; however will be expected to provide training and leadership to other study coordinators within the department, as needed.
Examples of Work Performed
- Serves as the primary clinical research coordinator for industry sponsored and investigator-initiated clinical trials in systemic lupus erythematosus
- Ensures compliance with Food and Drug Administration (FDA), the Office for Human Research Protections (OHRP), Good Clinical Practice (GCP), Institutional Revew Boards (IRB), Health Insurance Portability and Accountability Act (HIPAA), University of Colorado Hospital, University of Colorado Denver (UCD) and other pertinent regulatory agencies
- Oversees subject recruitment, screening, consenting, coordination of clinical visits/protocol procedures and data collection.
- Collaborates with investigators, clinical staff and research staff to ensure study procedures are performed per protocol
- Conducts medical record review, subject study visits and provides protocol specific subject education.
- Prepares, submits and maintains documents for IRB, hospitals and sponsors
- Inform clinical trial budget development.
- Coordinates payment of study expenses, such as medical service fees, IRB fees and study subject payments
- Recognizes adverse events and serious events and promptly notifies appropriate parties
- Develops SOPs for clinical trial operation within division.
- Participates in protocol meetings, trainings and audits
- Participates in meetings and training provided by UCD and affiliates, such as Research Advisory Forum (RAF) and Rheumatology division and Lupus Clinic education sessions
- Performs phlebotomy and pharmacokinetic sampling and collects basic clinical measurements, including vital signs
- Collects, processes and ships biological research samples
- Works collaboratively and helps with periodic cross-coverage of other PRA staff within the Rheumatology Clinical Research Program
Knowledge, Skills, and Abilities
- Familiarity with FDA, OHRP, GCP, International Council for Harmonization of Technical Requirements for Pharmaceuticals (ICH), and HIPAA regulations
- Knowledge and experience with IRB policies and procedures
- Strong computer skills. Proficiency with use of Microsoft Excel, Outlook, Word, and other University and Sponsor systems, as required
- Excellent interpersonal communication, organizational skills, and ability to problem solve and multi-task
- Good command of the English language, both written and verbal
- Knowledge of common pharmaceutical terminology
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.
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.
- Education: bachelor’s degree from an accredited college or university or equivalent experience
- License: Must possess and maintain a Licensed Practical Nurse (LPN) or Registered Nurse (RN) license with the Colorado Department of Regulatory Agencies (DORA) (Please attach a copy of your transcripts, diploma or certificate)
- Training & Certification: must possess and maintain valid IV certification.
Applicants must meet minimum qualifications at the time of hire.
- Experience: minimum of two years’ experience with coordinating/managing clinical research activities with at least 6 months of patient interaction. Clinical trial experience is desired.
- Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC)
Applications are accepted electronically at CU Careers, refer to requisition ID: 19450
When applying, applicants must include:
- A letter of application which specifically addresses the job requirements and outlines qualifications
- A current Resume/CV
- The names, addresses, daytime telephone numbers and e-mail addresses for three professional references, either attached to your resume/CV or uploaded as a separate document
Please do not submit any of your application material (via email) to the job posting contact.