Research Services Clinical Sciences Program Director
- Employer
- University of Colorado Anschutz Medical Campus
- Location
- Denver, CO
View more
- Administrative Jobs
- Academic Affairs, Research Staff & Technicians, Institutional & Business Affairs, Program Administration, Technology, Analysts & Programming
- Employment Type
- Full Time
- Institution Type
- Four-Year Institution
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Description
University of Colorado | CU Anschutz Medical CampusSchool of Medicine – Department of Medicine, Division of Infectious DiseasesOfficial Title: Research Services Program DirectorWorking Title: Research Services Clinical Sciences Program DirectorPosition #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 employeesThe 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_2Denver: https://www.ucdenver.edu/coronavirusExemptions vary by campus location/department. Campus/Unit-Specific Exemptions:
Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: May 12, 2022
Unposting Date: May 17, 2022, 11:59:00 PM
University of Colorado | CU Anschutz Medical CampusSchool of Medicine – Department of Medicine, Division of Infectious DiseasesOfficial Title: Research Services Program DirectorWorking Title: Research Services Clinical Sciences Program DirectorPosition #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 employeesThe 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_2Denver: https://www.ucdenver.edu/coronavirusExemptions 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.
- 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.
- 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.
- 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.
- 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).
- 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.
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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