Description

University of Colorado School ofMedicine

 University ofColorado Denver | Anschutz Medical Campus

Department of Pediatrics– Section of Infectious Disease

Data Coordinator (Professional Research Assistant)

Position #684549 – Requisition #15681

 

The University of Colorado Denver | Anschutz Medical Campusseeks individuals with demonstrated commitment to creating an inclusivelearning and working environment.  We value the ability to engageeffectively with students, faculty and staff of diverse backgrounds.

 

The University of Colorado Denver |Anschutz Medical Campus is a public research university serving more than18,000 students. We award nearly 4,000 degrees each year, including moregraduate and professional degrees than any other Colorado institution. With oursolid academic reputation, award-winning faculty and renowned researchers, weoffer more than 140 highly rated degree programs through 13 schools andcolleges. The university receives over $400 million in research awards eachyear. In addition to the wide array of health-related programs and facilitiesoffered at CU Anschutz in Aurora, Colo. a significant number of undergraduateand graduate degree programs are taught at CU Denver, our comprehensive campusin the heart of downtown Denver—one of America’s most vibrant urban centers. CUDenver is located steps from the Denver Center for Performing Arts and the LoDoDistrict affording our students, faculty and staff access to a broad array ofacademic, professional, community, recreational and cultural outlets.

TheUniversity of Colorado Anschutz Medical Campus ranks among the top institutionsnationally in clinical care, education and research. Its 230-acre campus,designed to enhance collaboration and interprofessional education, hosts theCollege of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, andPublic Health; the Graduate School; a Health Sciences Library; and twohospitals. Strategically located contiguous to the campus are a biosciencesresearch park and the Veterans Hospital. CU Anschutz offers two undergraduatedegrees, 35 graduate degrees, and five first-professional programs. More than4,000 students learn alongside faculty members who also make meaningful medicaldiscoveries and provide expert clinical care through 1.5 million patient-visitsannually. A hub for research and innovation, CU Anschutz receives over $400million in research awards each year and has filed 1,300 patent applicationsand formed 53 new companies since 2002. 

 

A national leader in health care and life sciences,CU Anschutz is the only comprehensive academic health sciences center inColorado and the largest in the Rocky Mountain region. Located in Aurora,Colo., it is one of the newest education, research and patient care facilitiesin the world. With six schools and colleges, CU Anschutz trains the healthsciences workforce of the future by blending education, research and clinicalcare all in one place. This strategic collaboration among diverse health carefields allows knowledge to travel directly from the research bench to thepatient’s bedside. Read CU Anschutz Quick Facts here.

 

JobSummary:

TheDepartment of Pediatrics, Section of Infectious Disease as part of the Universityof Colorado Denver | Anschutz Medical Campus has an opening for a full-time Data Coordinator (Professional Research Assistant). Thisposition is responsible for: Clinical research data coordination within the CHIP HIVresearch program.  This includes coordinatingdata for study implementation, data collection, data abstraction, data submissionand data follow up in a timely and accurate manner.  Will maintain a quality assurance program that keeps CHIPresearch efforts in excellent standing with national, international, and localresearch monitoring groups. Clinical trials can include HIV and Vaccine researchstudies involving infants, children, adolescents, young adults, women andpregnant women living with and affected by HIV, as well as HIV preventiontrials and a variety of vaccine trials. These studies may include working withthe LGBTQ, MSM and transgender community.

 

Examples of Work Performed:

Research Data Coordination:

• Coordinate, facilitate and participate in all datamanagement activities from initiation of protocol, manage the data collection, chartreviews, forms submission, completion of study visits, responses to dataqueries, through completion of data-lock with minimal oversight.
• Support the clinical data for multiple complex researchprotocols.
• Complete research documentation utilizingmedical records, lab guidelines, protocol information and other resources foraccurate completion and submission of research records
• Collaborates withclinical research team in obtaining grading levels for toxicities includingassessment of clinical significance of all lab and test results and relatednessof adverse reactions to study product according to protocolguidelines.
• Work with CHIP team to identify and reportadverse event and protocol deviations to study team, sponsor, and IRB withindesignated time-frames
• Enter data into multiple research data bases
• Manage protocol changes as new information isreleased from sponsors
• Assist with Institutional Review Board (IRB)submissions as needed
• Collaborate with ancillary clinical serviceswithin Children’s Hospital Colorado to fulfill protocol data requirements
• Establish procedures, databases, and filingsystems to ensure appropriate recordkeeping
• Track patient participation
• Problem solve as it relates to research project
• Develop SOPs as needed
• Assumes responsibilityfor accuracy, timeliness, and thoroughness of protocol management to ensure thehighest standards of research.
• This position will havelimited direct participant contact
• Perform other related duties as assigned

Quality Assurance:

• Organize, conduct, and maintain responsibilityfor quality assurance procedures
• Respond to sponsor queries for research data recordsin requested time
• Resolve all discrepancies and delinquencies indata collection
• Validate quality of data elements/data editing
• Preparation and participation in site monitorvisits
• Maintain regulatory files including protocolfiles, informed consents and other materials as required

PLEASE NOTE:Candidates will be responsible for travel expenses related to the interviewprocess and any relocation expenses, if applicable.

Salary and Benefits:

The hiringsalary for this position is $35,000 - $48,000 and is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation.

TheUniversity of Colorado offers a full benefits package. Information onUniversity benefits programs, including eligibility, is located at Employee Services.

The University of Colorado Denver |Anschutz Medical Campus is dedicated to ensuring asafe and secure environment for our faculty, staff, students and visitors. Toassist in achieving that goal, we conduct background investigations for allprospective employees.

 

TheImmigration Reform and Control Act requires that verification of employment eligibilitybe 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 withdisabilities.

 

Yourtotal compensation goes beyond the number on your paycheck. The University ofColorado provides generous leave, health plans and retirement contributionsthat add to your bottom line.

 

Benefits: https://www.cu.edu/employee-services/benefits.

TotalCompensation Calculator: https://www.cu.edu/employee-services/total-compensation(for questions, please contact Jessica Martella at Jessica.Martella@childrenscolorado.org)

 

Diversity and Equity:

Pleaseclick here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx 

 

TheUniversity of Colorado Denver | Anschutz Medical Campus is committed torecruiting and supporting a diverse student body, faculty and administrativestaff. The university strives to promote a culture of inclusiveness, respect,communication and understanding. We encourage applications from women, ethnicminorities, persons with disabilities and all veterans. The University ofColorado is committed to diversity and equality in education and employment.

Qualifications

Minimum Qualifications:

• Bachelor’s Degree
• Clinical research experience

Conditions of Employment:

• Must be willing and able to pass a 10 panel drug test through Children's Hospital Colorado
• Must be willing and able to pass a national criminal background and sex offender check

Preferred Qualifications:

• Master's degree
• 2 or more years’ experience in clinical research
• Familiarity with multi-center national and international trials
• Experience working with electronic databases and date entry
• Experience in the medical field
• Experience in data coordination

Knowledge, Skills, and Abilities:

• Strong interpersonal and communication skills (oral and written)
• Understanding and experience with Source Documentation Guidelines
• Current on all HSP, HIPAA, GCP and other required research certifications
• 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
• Extreme attention to detail with ability to accurately prioritize workflow
• Candidate must feel comfortable working with the diverse population the CHIP clinic serves

Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: Feb 7, 2019
Unposting Date: Ongoing