Professional Research Assistant - Regulatory Compliance Coordinator

Job description

Description
University of Colorado School of Medicine

University of Colorado | CU Anschutz Medical Campus

School of Medicine, Department of Pediatrics

Section of Infectious Diseases– Children's Hospital Immunodeficiency Program (CHiP)

Professional Research Assistant– Regulatory Compliance Coordinator 

Position #00775635– Requisition #20815

* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *

The University of Colorado 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 Pediatrics, Section of Infectious Diseases– Children's Hospital Immunodeficiency Program (CHiP)has an opening for a full-time Professioanl Research Assistant– Regulatory Compliance Coordinator position. 

Nature of Work: 

  • At Children’s Hospital Immunodeficiency Program (CHiP) we have a clear vision to be a place where a diverse mix of talented people want to come and stay and do their best work.  We pride ourselves on bringing the best medical care and research to the patients we serve to improve the health of individuals. We endeavor to demonstrate CHiP’s dedication to promoting diversity, multiculturalism, and inclusion in in all of our care. 
    • Regulatory Compliance Coordinator provides research compliance expertise and support to the CHiP research program specializing in COVID-19 vaccine and prevalence, HIV treatment and prevention, and childhood vaccine research.
    • The Compliance Coordinator ensures that the various research compliance activities and programs within CHiP adhere to federal, state, and institutional policies.
    • The Compliance Coordinator will complete submissions to various Institutional Review Boards (IRBs) and other regulatory entities for the CHiP program.
    • Regulatory Compliance Coordinator will operate at an intermediate level and function fully and independently.   
The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here.

Position Emphasis:

  • Oversee, prepare and submit accurate and timely IRB submissions (initial applications, amendments, continuing reviews, promptly reportable information, adverse events, protocol deviations etc) and process post-approval documentation. Manage ongoing correspondence with IRB and sponsors to keep all materials updated in a timely manner in accordance with local guidelines and for the ongoing management of research to maintain high program standards 30%
  • Manage all protocol-related changes as information is released from sponsors (Protocol Amendments, Letters of Amendment, Clarification Reports, IND Safety Reports, Investigator’s Brochures, Package Inserts, adverse events and protocol deviations,etc.) and submit to regulatory entities within specified timeframes 25%
  • Create informed consent documents in compliance with sponsor and institutional guidelines, and manage tracking of approved consent documents 10%
  • Establish standard operating procedures, databases, and filing systems to ensure appropriate recordkeeping. Maintain site regulatory files including protocol-specific essential documents, research staff files(CVs, trainings, medical licenses), laboratory CLIA/CAP certifications, and other materials 10%
  • Complete submissions through the Human Subjects Research (HSR) Portals for local institutional reviews at Children’s Hospital Colorado and/or the University of Colorado Denver Anschutz Medical Campus.  Collaborate with Children’s Hospital research compliance team to maintain excellent standards 8%
  • Preparation for site monitor visits, and timely follow up 6%
  • Collaborate with Principal Investigator (PI) and research team to ensure compliance and submission timeliness. Provide research team with guidance on policies, procedures, local and federal guideline, and compliance. 5%
  • Obtain signatures from investigators and research staff on financial disclosure forms, training logs, delegation of authority logs, and other documents 5%
  • Other Duties as assigned 1%
  • PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

    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.

    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.

     

    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 Qualifications:

  • Bachelor’s Degree and 2 years research compliance experience
  • OR Master’s degree in relevant area
  • Some experience with Institutional Review Board submissions
  • Applicants must meet minimum qualifications at the time of hire.

    Conditions of Employment:

    • Must be willing and able to successfully pass a 10-panel drug test
    • Must be willing and able to successfully pass a national criminal background check
    Preferred Qualifications:

  • 2+ years’ experience with Institutional Review Board (IRB) submissions
  • Familiarity with multi-center trial submissions
  • Proficient in Adobe Acrobat Pro
  • Experience working with a variety of databases
  • Competencies:

  • Ability to handle sensitive and or confidential information
  • Candidate must feel comfortable working with the diverse population the CHiP clinic serves
  • Ability to communicate effectively and professionally with the University community, study sponsors, and federal agencies
  • Must possess excellent interpersonal skills and feel comfortable with the diverse population the CHiP clinic serves
  • Ability to work independently, within a strong team environment
  • Ability to manage multiple responsibilities, often under time pressures
  • Knowledge and understanding of federal regulations
  • Ability to interpret rules, regulations, and policies for use in program and processes
  • Strong attention to detail
  • Ability to accurately prioritize workflow
  • Proficient in computer software applications such as Microsoft Excel, Word, and PowerPoint
  • Excellent ability to support one another using good communication skills and implementing healthy team dynamics


  • Job Category: Faculty
    Primary Location: Aurora
    Schedule: Full-time
    Posting Date: Apr 13, 2021
    Unposting Date: Ongoing

     

     

     

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    Job No:
    Posted: 4/15/2021
    Application Due: 6/14/2021
    Work Type: Full Time
    Salary: