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 Department of Dermatology’s growing Clinical Research Unit seeks a Professional Research Assistant (PRA) to support multiple clinical trials, serve as a study coordinator, and assist with regulatory communication and compliance in a fast-paced environment. This includes study implementation, preparation for and assistance with clinical visits, data collection and submission in a timely and accurate manner, and maintaining a quality assurance program that keeps the department’s research efforts in excellent standing with national and local monitoring groups. These responsibilities require the ability to think creatively, work independently, communicate clearly, and interact professionally with a variety of people and groups.
The University of Colorado Denver’s Department of Dermatology has a growing clinical research unit devoted to improving the understanding and treatment of dermatological conditions. With a variety of grant and industry sponsored research projects, there is no “regular” day. Some duties will include:
Responsibilities include, but are not limited to the following:
Coordinating clinical research visits and collecting/recording data. This position includes comprehensive direct patient contact (i.e., performing phlebotomy, taking vital signs, administering questionnaires and surveys, and coordinating drug and/or device dispensing and accountability) with a high-level of ethics and integrity
Participating in study recruitment initiatives that include communicating with patients who have expressed interest in the study, pre-screening activities, screening patients, and documenting patient enrollment statuses in collaboration with the recruitment specialist
Managing research visit scheduling by collaborating and communicating with the whole clinical researchteam and our partners. This includes considering principal investigator schedule, patient schedules, clinic schedules, etc. in order for visit windows and the protocol requirements to be followed
Ensuring study quality meets the requirements of study protocols, department Standard Operating Procedures (SOPs), and research regulations and best practices (e.g., ICH guidelines, FDA code of Federal Regulations, and Good Clinical Practice (GCP)). Examples of this include proactively preventing deviations, creating source documents, creating backup plans, and ensuring principal investigator oversight
Working, communicating, and collaborating with various colleagues (e.g., principal investigator, clinicians, medical staff, sponsors, contract research organizations (CROs), and university research staff, finance and billing professionals, and regulatory team) at various stages of each study assigned. The PRA is responsible for providing excellent customer service to both internal and external stakeholders by presenting a positive image of the department and University
Managing accurate and timely documentation of all research activities and study correspondence (e.g., randomization, patient statuses and visits, chain of custody lab samples and study drug/device, billing notes, progress reports) that adhere to study protocols using various electronic information systems. This position will also be responsible for responding to study queries and monitor findings in a timely and professional manner
Overseeing lab activities, such as basic processing technique (centrifuge, aliquot serum, blood slides, etc.), and shipping and tracking laboratory samples
Participating in subspecialty team meetings and clinical research coordinator meetings. Collaborating with team members for backup needs, sharing learning experiences, and applying learning opportunities
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.
Bachelors’ degree in a health related field
Experience working in human subjects’ research
Experience working in a health care setting with direct patient contact
Clinical research drug and/or device study coordination experience
Research training: CITI, IATA, blood borne pathogens, Basic Life Support (BLS), GCP
Experience completing documentation and performing tasks routinely used in clinical research, such as understanding federal regulations and Good Clinical Practice (GCP)
ACRP or SOCRA certification
Experience performing ECGs, phlebotomy, and vital signs
Experience with Epic (or similar electronic medical record system) and CTMS systems (OnCore)
Experience with RedCap and eCRF databases
Required Competencies/Knowledge, Skills and Abilities
Outstanding interpersonal and communication skills with the ability to work independently and within diverse team structures
Respect patient rights and put patient safety first, excellent patient rapport
A positive, motivated, engaged, and caring attitude
Great attention to detail and quality
Ability to work with colleagues and patients in a confidential and professional manner
Follow best practices in research (ICH guidelines, GCP, FDA guidelines)
Ability to follow and execute a study protocol and proactively prevent deviations
Ability to follow direction of the PI and direct supervisor, follow all department SOPs and department policies
Good documentation practices
Dedication to professional development and life-long learning
Ability to be adaptable, flexible, and to think on your feet
Organization: *H0001 -- Anschutz Medical Campus
Title: Professional Research Asst
Requisition ID: 15857