University of Colorado Professional Research Assistant in Aurora, Colorado
University of Colorado – School of Medicine
Professional Research Assistant (Clinical Trials Coordinator)
Department of Dermatology/ 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.
The Department of Dermatology’s growing Clinical Research Unit seeks a Professional Research Assistant (PRA) to serve as a study coordinator, support multiple clinical trials, 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 adhering to 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
Coordinating research patient visit scheduling by collaborating and communicating with the whole clinical research team 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
Coordinating site visits (in-person and remote) with sponsors by collaborating with all relevant university departments. This includes considering principal investigator schedule, multiple university departments, and university protocols related to site visits 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
Ensuring accurate and timely documentation of relevant research activities and study correspondence (e.g., data upload to electronic systems, 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
Conducting 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
Performing other duties as assigned by Clinical Research manager and Investigators
Salary and Benefits:
The salary range ( or hiring range ) for this position has been established at $37,500 to $52,000.
The salary of the finalist(s) selected for this role will be set based on a variety of factors, including but not limited to, internal equity, experience, education, specialty and training.
The above salary range ( or hiring range ) represents the University’s good faith and reasonable estimate of the range of possible compensation at the time of posting.
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.
Bachelors’ degree in a health-related field
2 years’ experience working in human subjects’ research
2 years’ experience working on multiple clinical research studies simultaneously
2 years’ experience working in a health care setting with direct patient contact
Applicants must meet minimum qualifications at the time of hire.
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
Understanding of medical terminology as well as standard clinical procedures and protocols. 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
Primary Location: Aurora
Job Category Faculty
Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS
Posting Date Feb 8, 2021
Unposting Date Ongoing
Posting Contact Name Joyce Nelson
Posting Contact Email Joyce.firstname.lastname@example.org
Posting Number 00050339
Req ID: 20146
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.