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Research Services Clinical Sciences Program Director

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Description
University of Colorado | CU Anschutz Medical Campus

School of Medicine – Department of Medicine, Division of Infectious Diseases

Official Title: Research Services Program Director

Working Title: Research Services Clinical Sciences Program Director

Position #00796989 – Requisition #25961

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

This position posting is an internal CU-only search and only open to current CU employees

The University of Colorado has a requirement for COVID-19 vaccinations and full completion thereof by 9/1/21 or upon start date.  Information regarding this requirement, and exemptions can be found at:

Anschutz: https://www.ucdenver.edu/docs/librariesprovider284/default-document-library/3000-general-admission/3012---covid-19-vaccination-requirement-and-compliance.pdf?sfvrsn=4e9df3ba_2

Denver: https://www.ucdenver.edu/coronavirus

Exemptions vary by campus location/department.

Campus/Unit-Specific Exemptions:

    Anschutz Campus – Exemptions are allowed for medical or religious reasons.Denver Campus - Exemptions are allowed for medical, religious, or personal reasons.Consolidated/Central Services Administration – Will follow Anschutz policy on exemptions.
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 Medicine, Division of Infectious Diseases has an opening for a full-time University Staff (unclassified) Research Services Clinical Sciences Program Director position.

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.

About the Lab:

The Colorado AIDS Clinical Trials Unit (ACTU) conducts a wide range of clinical trials offering experimental treatments with antiretrovirals and immune therapy for adults at all stages of HIV disease. Studies of therapies for opportunistic infections are also available. The Colorado ACTU is one of the 30 ACTUs that comprise the AIDS Clinical Trials Group (ACTG). ACTG trials are funded by the National Institute of Allergy and Infectious Diseases (NAIDS). Study medications and related tests are in most cases free of charge. Additional HIV/AIDS studies sponsored by drug companies are available. The Colorado ACTU is located at the University of Colorado Anschutz Medical Campus.

Nature of Work:

Clinical Science Program Directors perform clinical research related functions which may include patient-oriented research or research conducted with human subjects. Patient-oriented research includes mechanisms of human disease, therapeutic interventions, clinical trials, or development of new technologies. Clinical Science Program Directors may also assist with epidemiologic and behavioral studies and/or outcomes research and health services research. Clinical Science Program Directors independently research, plan, develop and implement the entire clinical research/science program(s) for a department, division(s), or center(s). The Program Director develops strategic objectives and goals and implements aligned strategies. The Program Director is a senior leader responsible for the overall success of the program and provides leadership and direction to one (1) or more Clinical Science Manager(s). The Program Director also provides policy guidance and interpretation to leaders, team members and other stakeholders on a wide variety of personnel and operational issues assuring compliance with Federal, University, and departmental rules and regulations.

Some assignments will not move beyond this level.

Examples of Duties Performed:

    Provide oversight, direction and leadership for all clinical research operations within division(s), center(s) and/or department.Initiate and set goals for programs according to the strategic objectives of division(s), center(s), and/or department.Develop and approve budgets and operations.Plan the programs from start to completion including deadlines, milestones and processes.Provide oversight of Good Clinical Practice (GCP) in all studies.Develop program/project goals and communicate goals and outcomes with a variety of stakeholders.Direct tactical and strategic program/project development and planning.Direct program budget development processes, including grant writing and submission processes, and regularly reviews to ensure alignment.Lead and direct program/project start up and close out functions.Liaise and coordinate with a variety of program/project stakeholders including, but not limited to, program/project sponsors, regulatory agents, pharmaceutical representatives, and clinic/hospital staff.Ensure program/project compliance with Food and Drug Administration (FDA) and other regulatory bodies.Coordinate site visits and other meetings with key stakeholders. Develop and maintain a variety of reports and communicate and present data to stakeholders.Develop and implement community outreach and engagement initiatives.Oversee the day to day operations of clinical trials and studies, when needed.May perform duties and responsibilities of Clinic Research Professionals when necessary.
Additional Duties & Responsibilities:

    Provides overall management and coordination of the clinical research operations for the Colorado AIDS Clinical Trials Unit (ACTU) and the University of Colorado Hospital Clinical Research Site (CRS).Responsible for planning, management and oversight of implementation of complex, multi-center clinical trials in the treatment and prevention of infectious diseases.Ensures full compliance with FDA, OHRP, IRB and University of Colorado requirements for human subjects research.Ensures full compliance with Good Clinical Practice requirements and HIPAA regulations.Supervises CRS research staff including the regulatory manager, research nurses, research nurse practitioners, data managers, and outreach/recruitment specialists to ensure proper progress and completion of studies.Provides training and guidance for CRS staff for all aspects of conducting complex and multi-center trials, including regulatory compliance, research subject recruitment, screening, consenting, coordination of study visits/procedures and data management.Evaluates individual CRS staff performance annually and provide feedback.Works collaboratively with the ACTU Laboratory Manager to ensure proper handling, processing, storage and tracking of research specimens per study requirements.Conducts study visits and collect blood specimens (venipuncture) to meet study requirements as needed.Ensures that recruitment stays on track with project timelines in order to meet study recruitment goals through: 1) development and implementation of recruitment strategies to identify potential participants and engage study staff to assist in identifying and enrolling participants; 2) Proactive identification and monitoring of barriers to recruitment and developing innovative solutions to overcome them.Develops and implements metrics to monitor CRS progress at regular intervals and reports results to ACTU Principal Investigator.Independently reviews clinical research literature to design and implement appropriate research methodologies, techniques and procedures.Assists faculty researchers in the planning, design and implementation of research projects including establishment of project priorities, schedules of events, study timetables and costs.Provides education, resources and consultation to other investigators for the development and implementation of investigator-initiated studies.
    Assist the ACTU Principal Investigator with the submission of new research grant applications, preparation of research study budgets and budget justifications and other supporting documents.Meets with the ACTU Principal Investigator weekly to review progress.
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.

Minimum Qualifications:

    Bachelor’s degree in any field.A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.
Six (6) years clinical research or related experience.Two (2) years management experience in a clinical research setting.Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

    Master’s degree in a science or health related field.Four (4) years supervisory or management experience in a clinical research setting.Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
Competencies, Knowledge, Skills, and Abilities:

    A business acumen with a strategic ability.Excellent organizational and leadership skills.An analytical mindset with great problem-solving abilities.Ability to set goals, motivate team members to achieve results. Knowledge of supervisory techniques, management principles, and organizational leadership.Expert knowledge and understanding of federal regulations and Good Clinical Practice (GCP).Ability to communicate effectively, both in writing and orally.Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.Outstanding customer service skills.Demonstrated commitment and leadership ability to advance diversity and inclusion.Knowledge of basic human anatomy, physiology medical terminology.Ability to interpret and master complex research protocol information.
PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

Salary and Benefits:

The starting salary rate (or hiring rate) for this position has been established at $90,000 per year.  

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.

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: http://www.cu.edu/node/153125

Diversity and Equity:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at [email protected].

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.

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.



Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: May 12, 2022
Unposting Date: May 17, 2022, 11:59:00 PM
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