Professional Research Assistant - Clinical Trials Manager

Job description

Description
University of Colorado, Anschutz Medical Campus

Department of Medicine, Division of Pulmonary Sciences and Critical Care Medicine

Pulmonary Vascular Disease (PVD) Center

Clinical Trails Mananger (PRA)

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.

Nature of Work

The Pulmonary Vascular Disease (PVD) Center within the Department of Pulmonary Sciences and Critical Care Medicine has an opening for a full-time Clinical Research Manager.   The role of the PVD Research Manager is to oversee various research projects, including clinical trials, registry studies, and biorepositories, for the Pulmonary Vascular Disease Center and the Center for Lungs and Breathing Clinical Core Research Programs. We are seeking an individual who is collaborative, communicative, detail-oriented, organized, proactive, able to think critically, focused on quality, dedicated to personal growth, and highly motivated.

 Clinical trials are a vital part of the development of any new medication or medical device.    Clinical trial managers not only oversee the trial at the research site, but also act as liaison between the trial site PIs and the study sponsor. People in these positions carry the responsibility for making sure the trial is conducted appropriately.

The position is located at the Anschutz Medical Campus.    We are the premier research university in Colorado, serving more than 30,000 undergraduate, graduate and health professions students in Denver, Aurora and online and awarding nearly 4,000 degrees each year.  The renowned researchers and award-winning faculty offer more than 100-degree programs through 13 colleges and schools.   The Anschutz Medical Campus includes over 5 million square feet of research, educational and clinical space on 227 acres.

Clinical Trail Manager Responsibilities:

Serve in an administrative and supervisory capacity for the Pulmonary Vascular Disease program and the Division’s Clinical Core Research Faculty in  the Center for Lungs and Breathing.   Provide regulatory and financial oversight and assist with staff recruiting, work assignments, training, and supervision during the conduct of their clinical trials. Duties include:

  • Collaborating with Site PI, Sub-Is, study sponsors, clinical staff, and clinical research staff to ensure trial compliance per individual project goals
  • Enrollment of patients and follow up of enrolled patients as required for individual studies.
  • Preliminary contract review, contract submission to the Office of Grants and Contracts and collaboration with University Contract Attorneys regarding submitted contracts
  • Budget preparation and negotiations with study sponsors
  • Controls and regularly monitors revenue and expenditure activity for each source of funds and reports
  • Preparing and submitting Invoices to Sponsors for work conducted
  • Submitting payments for CU and UCHealth services utilized during the conduct of the trail.
  • Coordinating and supervising the clinical research team
  • Assuring the Clinical Research Team training is completed and documented per established guidelines
  • Conducting regular meetings with research team
  • Preparing research coordinator’s evaluations
  • Overseeing site visits including site qualification visits, site initiation visits, monitoring visits (as needed) and site audits.
  • Creating and implementing study-specific clinical monitoring tools and documents as needed.
  • Participation in investigator’s meetings as needed
  • Overseeing and participating in site research activities as needed, including:
  • Scheduling and conducting study visits
  • Screening, consenting and enrolling study participants
  • Collecting, processing and storing samples for research
  • Medication compliance tracking
  • Assessment of adverse drug reactions and other serious adverse events
  • Patient education and follow-up
  • Routine meetings with monitors to reconcile data management issues
  • Preparing and submitting compliance documentation for the institutional review board
  • Submission to the Human Research Subjects Portal for UCH-RSS review and approval
  • Maintenance of databases
  • Abstracting data from patient charts and electronic medical records
  • Service in the following areas:
  • Clinical Research Advisory Forum (RAF)
  • Clinical Research Coordinators Committee (CRC)
  • Support with local PH awareness and fundraising event
  • Supervision Received

    This position is supervised by Dr. Todd Bull, the Director of the Pulmonary Vascular Disease Program and the Director for the Center for Lungs and Breathing.

    Supervision Exercised

    The Clinical Research Manager will supervise research coordinators in both the Pulmonary Vascular Disease Center and the Center for Lungs and Breathing Clinical Core.

    Salary and Benefits: 

    The salary range (or hiring range) for this position has been established at $35,600 to $76,000.

     

    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.



    Qualifications
    Minimum Requirements:

      Bachelor’s Degree3+ years experience in clinical research 3+ years experience in budgetary and IRB experience.  
    Applicants must meet minimum qualifications at the time of hire.

    Preferred Requirements

      People management experience


    Job Category: Faculty
    Primary Location: Aurora
    Schedule: Full-time
    Posting Date: Feb 12, 2021
    Unposting Date: Ongoing

     

     

     

    Diversity Profile: University

     

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    Job No:
    Posted: 2/13/2021
    Application Due: 5/14/2021
    Work Type: Full Time
    Salary: