Professional Research Assistant - Infectious Disease
University of Colorado School of Medicine
University of Colorado Denver | Anschutz Medical Campus
Department of Pediatrics - Section of Infectious Diseases--CHIP
Professional Research Assistant
Position #684549 - Requisition #14997
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 University of Colorado School of Medicine, Department of Pediatrics, Section of Infectious Diseases (CHIP), has an opening for a full-time Professional Research Assistant to work at the Anschutz Medical Campus in Aurora. The Children's Hospital Immunodeficiency Program (CHIP) provides comprehensive health care integrated with clinical trial participation to children, adolescents, young adults and pregnant women living with or affected by HIV. CHIP is comprised of a multi-disciplinary team including a clinical care team, psychosocial support team, research team, outreach/prevention team, and administrative support. CHIP is a study site for multi-center clinical trials from the HIV Prevention Trials Network (HPTN), the International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) network, the Pediatric HIV/ AIDS Cohort Study (PHACS) network, as well as other federal and industry-sponsored trials.
The University of Colorado Denver | 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 University of Colorado Denver | Anschutz Medical Campus is a comprehensive urban research university serving more than 28,000 students in metropolitan Denver and online. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado public institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer 119 highly rated degree programs through 13 schools and colleges. The University of Colorado Denver | Anschutz Medical Campus is well known for its distinctive and highly productive research programs, its world-class health facilities at the Anschutz Medical Campus and its well-established partnerships in business, industry and government. These campuses currently have over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at our Anschutz Medical Campus, a significant number of undergraduate and graduate degree programs are taught at our comprehensive campus in the heart of downtown Denver. Denver is one of America's most vibrant urban centers and the downtown campus, located just steps from the Denver Center for Performing Arts and the LoDo District, affords our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets.
The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002.
Clinical research coordination within the CHIP HIV research program. This includes study implementation, data collection and submission in a timely and accurate manner, and maintaining a quality assurance program that keeps CHIP research efforts in excellent standing with national, international, and local research monitoring groups. Clinical trials can include HIV research studies involving infants, children, adolescents, young adults, women and pregnant women living with and affected by HIV, as well as HIV prevention trials and a variety of vaccine trials. These studies will include working with the LGBTQ, MSM and transgender community.
Examples of Work Performed:
- Under supervision of Clinical Research Manager, collaborate with PI and clinical team to implement complex research studies, including identify and enroll eligible patients to study, consent, data collection, forms submission, completion of study visits and responses to data queries
- Complete research documentation utilizing medical records, lab guidelines, protocol information and other resources for accurate completion and submission of research records
- Enter data into research data base
- Conduct research visits in accordance with the protocol, including scheduling, preparing assessments, consenting, completing study procedures, and administering patient interviews
- Manage protocol changes as new information is released from sponsors
- Assist with Institutional Review Board (IRB) submissions as needed
- Collaborate with ancillary clinical services departments within Children's Hospital Colorado to fulfill protocol requirements
- Establish procedures, databases, and filing systems to ensure appropriate recordkeeping
- Track patient participation
- Work with CHIP team to identify and submit adverse event reports to study team, sponsor, and IRB within designated timeframes
- Problem solve as it relates to research project
- Develop SOPs as needed
- Assume responsibility for accuracy, timeliness, and thoroughness of protocol management to ensure the highest standards of research.
- Accurately ensure billing/invoicing are tracked and reconciled.
- This position will have limited direct participant contact
- Other duties as assigned
- Organize, conduct, and maintain responsibility for QA procedures
- Respond to sponsor queries for research data records in requested time
- Resolve all discrepancies and delinquencies in data collection
- Validate quality of data elements/data editing
- Prepare for site monitor visits
- Ensure accurate and complete informed consent process and tracking
- Maintain regulatory files including protocol files, informed consents and other materials as required
PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.
Salary and Benefits:
The hiring salary for this position is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation.
The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services.
The 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 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 (for questions, please contact [email protected])
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.
- Bachelor's Degree in science, healthcare or closely related field
- 1 year of clinical research coordination experience
Condition of Employment:
- Must successfully pass a drug test through Children's Hospital Colorado
- Must be willing and able to pass a national criminal background and sex offender registry check
- Current and maintenance of HSP, HIPAA, GCP and other required research certifications
Required Competencies: Knowledge, Skills, and Abilities:
- Strong interpersonal and communication skills (oral and written)
- Understanding of Source Documentation Guidelines
- Knowledge of administering informed consent using Good Clinical Practice principles
- Demonstrated competency with Microsoft Office (Word, Excel)
- Familiar with electronic medical record documentation and review (preferably EPIC)
- Understanding of federal guidelines for serious adverse event reporting
- Ability to manage multiple responsibilities, often under time pressures
- Ability to work independently within a strong team environment
- Attention to detail with ability to accurately prioritize workflow
- Ability to work with the diverse patient population in the CHIP clinic
- Master's degree
- Familiarity with multi-center national and international clinical research trials
- Experience working with electronic databases and date entry
- Experience and ability to work with the LGBTQ community and people living with and at risk for HIV
- Experience with IRB submissions
Special Instructions to Applicants:Special Instructions to Applicants *Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Required Application Materials: When applying at www.cu.edu/cu-careers, applicants must include: 1. A cover letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV or resume 3. The names, addresses, daytime telephone numbers and email addresses for three professional references. If the references are not incorporated in the Resume/CV or in the application, attach as "List of References". Questions should be directed to Carrie Chambers at [email protected]
Reference checks are a standard step in our hiring process. You may be asked to provide contact information, including e-mail addresses, for up to 5 references if you are referred to the Hiring Authority for an interview. We will notify you prior to contacting both on and off-list references. Please do not submit any of your application material (via email) to the job posting contact.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:APPLICATION DEADLINE: - Review of applications will begin immediately and will continue until the position is filled.
Job Category: Faculty
Primary Location: Aurora
Department: H0001 -- Anschutz Medical Campus - 21016 - SOM-PEDS ID-GenOps
Posting Date: Oct 26, 2018
Closing Date: Ongoing
Posting Contact Name: Carrie Chambers
Posting Contact Email: [email protected]
Position Number: 00684549