Description

University of Colorado – School of MedicineSr. Professional Research Assistant 

TheUniversity of Colorado Denver l Anschutz Medical Campus seeks individuals with demonstratedcommitment to creating an inclusive learning and working environment.  Wevalue the ability to engage effectively with students, faculty and staff ofdiverse backgrounds.

 

The University ofColorado Denver | Anschutz Medical Campus seeks a Senior Professional ResearchAssistant - Clinical Trials Operations Manager to work in the Division ofCardiology the CU Anschutz Medical Campus in Aurora. The University of ColoradoDenver | Anschutz Medical Campus is committed to recruiting and supporting adiverse student body, faculty and administrative staff. The university strivesto promote a culture of inclusiveness, respect, communication andunderstanding.

 

The University of Colorado Denver | AnschutzMedical Campus is a public research university serving more than 18,000students. We award nearly 4,000 degrees each year, including more graduate andprofessional degrees than any other Colorado institution. With our solidacademic reputation, award-winning faculty and renowned researchers, we offermore than 140 highly rated degree programs through 13 schools and colleges. Theuniversity receives over $400 million in research awards each year. In additionto the wide array of health-related programs and facilities offered at CUAnschutz in Aurora, Colo. a significant number of undergraduate and graduatedegree programs are taught at CU Denver, our comprehensive campus in the heartof downtown Denver—one of America’s most vibrant urban centers. CU Denver islocated steps from the Denver Center for Performing Arts and the LoDo Districtaffording our students, faculty and staff access to a broad array of academic,professional, community, recreational and cultural outlets.

 

The University of Colorado Anschutz MedicalCampus ranks among the top institutions nationally in clinical care, educationand research. Its 230-acre campus, designed to enhance collaboration andinter-professional education, hosts the College of Nursing; the Schools ofDental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; aHealth Sciences Library; and two hospitals. Strategically located contiguous tothe campus are a biosciences research park and the soon-to-be-completed VeteransHospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees,and five first-professional programs. More than 4,000 students learn alongsidefaculty members who also make meaningful medical discoveries and provideexpert clinical care through 1.5 million patient-visits annually. A hub forresearch and innovation, CU Anschutz receives over $400 million in researchawards each year and has filed 1,300 patent applications and formed 53 newcompanies since 2002.

 

A national leader in health care and lifesciences, CU Anschutz is the only comprehensive academic health sciences centerin Colorado 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.

 

The University of Colorado Denver | AnschutzMedical Campus is committed to recruiting and supporting a diverse studentbody, faculty and administrative staff. The university strives to promote aculture of inclusiveness, respect, communication and understanding.

 

This position will manage the daily operationsof the Clinical Trials Program in the Division of Cardiology.

 Duties include, yet are not limited to:

• Develop and manage of a research matrix to monitor the progress of allClinical Trials within the Division of Cardiology.
• Assess feasibility andongoing monitoring of clinical trial workload across the Division of Cardiologywith the Division’s Clinical Director of Research.
• Collaborate with the Clinical Trials Finance Manager for research subjectpayment for University of Colorado Hospital, its departments, and CUMedicine.
• Assist the ClinicalTrials Finance Manager for budget development for upcoming clinical trials.
• Provide ongoing support for other research coordinators regarding UCDenver’s research processes and study-specific procedures.
• Supervision, training and mentoring of PRAs, serving as clinical trialcoordinators, in day to day processes and queryresolutions.
• Evaluate studyassignments and assess work load.
• Conduct periodic auditsof all the study documentation to ensure compliance and completeness.
• Work directly withindustry sponsor monitors to ensure completeness of all work submitted.
• Troubleshoot database resolution.
• Monitor and trackdata entry, subjectscreening and enrollment activities, and troubleshoot areas where needed forcompliance.
• Develop and submit accurate IRB applications, Continuing Review Reportsand all other required documents to support the conduct of clinicaltrialsresearch.
• Formulate consentdocuments in accordance with IRB regulations and sponsor-specific requests.
• Assist with the drafting of protocols, case report forms, and other requireddocuments for Investigator Initiated trials.
• Provide direction andsupport for subject recruitment, tracking of study visit schedule appointments.
• Serve as a clinicalresearch coordinator to obtain proper consents of subjects based on strictinclusion/exclusion criteria, as needed.

Salary and Benefits: 

Salary is commensuratewith skills and experience. The University of Colorado offers a full benefitspackage. Information on University benefits programs, including eligibility, islocated at Employee Services.

 

University of ColoradoDenver | Anschutz Medical Campus is dedicated to ensuring a safe and secureenvironment for our faculty, staff, students and visitors. To assist inachieving that goal, we conduct background checks for all new employees priorto their employment.

 

The Immigration Reformand Control Act requires that verification of employment eligibility bedocumented 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.

 

Your total compensationgoes beyond the number on your paycheck. The University of Colorado providesgenerous leave, health plans and retirement contributions that add to yourbottom line.

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

Total CompensationCalculator: https://www.cu.edu/employee-services/total-compensation

 Diversity and Equity: 

Please click here forinformation on disability accommodations:http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx 

 

The University of ColoradoDenver | Anschutz Medical Campus is committed to recruiting and supporting adiverse student body, faculty and administrative staff. The university strivesto promote a culture of inclusiveness, respect, communication andunderstanding. We encourage applications from women, ethnic minorities, personswith disabilities and all veterans. The University of Colorado is committed todiversity and equality in education and employment.

 

QualificationsMinimum Qualifications:

• Bachelor's degree inareas of clinicalresearch management AND 3 yearsfull-time research experience OR Master’s Degree.
• Full-time clinical research experience in most of theareas mentioned.
• Must have detailed knowledge of Good ClinicalPractice GCP/ICH guidelines in clinical research. 
• Substitutions for a degree are typicallyyear-for-year (6 years’ experience =master’s degree) in areas of clinical research management.

Knowledge, Skills and Abilities:

• Excellent computer skills including proficiency inMicrosoft Office products
• Excellent interpersonal communication, organizationalskills, and ability to problem solve and multi-task.
• Good command of the English language, both written and verbal.
• Excellent attention to detail and ability to interpretand master complex protocol information.

Preferred Qualifications:

• Candidates with additional researchexperience in most of the areas mentioned, with excellent communication and organizational skills, and an ability to work independently,are highly desirable.
• Knowledge of Good ClinicalPractices, FDA Rules and Regulations, NIH guidelines, ICH guidelines and HIPAA regulations in relation to clinical research.

Job Category: Faculty
Primary Location: Aurora
Schedule: Full-time
Posting Date: Dec 11, 2019
Unposting Date: Ongoing