Senior Professional Research Assistant
University of Colorado l Anschutz Medical Campus
Department of Medicine, Division of Infectious Disease
AIDS Clinical Trials Unit (ACTU)
Senior Professional Research Assistant
Position- 00782451– Requisition 20750
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.The University of Colorado Denver | Anschutz Medical Campus is a comprehensive urban research university serving more than 28,000 students in metropolitan Denver and online. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado public institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer 119 highly rated degree programs through 13 schools and colleges. The University of Colorado Denver | Anschutz Medical Campus is well known for its distinctive and highly productive research programs, its world-class health facilities at the Anschutz Medical Campus and its well-established partnerships in business, industry and government. These campuses currently have over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at our Anschutz Medical Campus, a significant number of undergraduate and graduate degree programs are taught at our comprehensive campus in the heart of downtown Denver. Denver is one of America’s most vibrant urban centers and the downtown campus, located just steps from the Denver Center for Performing Arts and the LoDo District, affords our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets. Job Summary: The Regulatory Manager of the AIDS Clinical Trials Group (ACTG) is a senior level professional responsible for the regulatory and administrative management of protocol approval process of HIV/AIDS and COVID-19 research studies under the research direction of Thomas Campbell, MD. Professional FieldProgram Administration, clinical research, human subject protection and research compliance Supervision ReceivedThe Regulator Manager reports functionally to the ACTG Site Coordinator and also receives direction, guidance, support and supervision from ACTG Site Leader. Examples of Work PerformedFinancial Management
- Negotiate industry clinical trials budgets and liaise with OGC and industry sponsors in executing clinical trials agreements (CTAs).
- Prepare calendar of events and billing plans for active protocols.
- Prepare billing sheets for research staff, record and file.
- Interface with relevant financial and human resource systems and hospital ancillary departments as necessary to manage the ACTGs operation and monitor financial performance.
- Authorize and monitor all charges to grant for patient ancillary charges and supplies.
- Reconcile UCH billing queries and patient bills for research visits.
- Manage participant reimbursement through subject payment vouchers and/or petty cash.
- Manage petty cash account. Reconcile financials, cash reimbursement checks and prepare annual tax.
- Review and authorize patient care charges to ACTG or SOC including hospitalization, ancillary department and clinic charges.
- Negotiate and prepare agreements (i.e. MTA, UPI fees) for outside services in support of approved protocols (MRI, leukapheresis, etc.).
- Enter research notes in EPIC, resolve account errors, and allocate costs to proper payer.
- Prepare and submit study invoices and cost reconciliation documentation for participants and site.
- Prepare and submit all required documentation for the UC Research portal, UCH Research Office, Institutional Biosafety and COMIRB: this includes Portal Submission Forms, pharmacy management plans, Cancer Center submissions, CTRC documentation, OnCore submissions as well as COMIRB/IBC applications, consents, continuing reviews, amendments and unanticipated problems/safety reports.
- Prepare and submit all required documentation to the Division of Allergy and Infectious Diseases (DAIDS) through the DAIDS Protocol Approval database: this includes initial reviews, continuing reviews, amendments, updated 1572’s or Investigator of Record forms, notices of deregistration.
- Notify local research team of IRB and DAIDS approvals, changes and study closures attaching supporting documentation.
- Notify pharmacy of approved Package Inserts and Investigator Brochures
- Maintain current Delegation Logs for each study.
- Assist with COMPASS recruitment database submissions.
- Maintain regulatory study binders for all ACTG and industry studies: download and print required documentation as well as maintain digital files for each study.
- Prepare regulatory study documents for on-site monitoring monitors at site visits.
- Maintain current GCP and HSP certification for all research personnel. Submit to DAIDS and IRB or study sponsor as required.
- Maintain current signed CV’s and medical license for all pharmaceutical and clinical research personnel. Provide as requested to DAIDS, IRB or study sponsor.
- Maintain Site Monitoring Log and Training Logs for all research studies.
- Write and maintain site-specific standard operating procedures (SOPs).
- Prepare monthly accrual reports for site staff meetings.
- Maintain ACTG financial disclosure forms as required by research studies.
- Maintain binder of safety reports.
- Manage receipt of and IRB submission requirements for investigator brochures and package inserts.
- A Master’s degree from an accredited college or university
- 5-7 years of experience in grant/financial management, clinical research administration, accounting, public health, or other related field
- Knowledge of human subject in research compliance regulations and requirements.
- Previous experience in a medical or health sciences research and clinical environment, preferably in an academic medical center
- Thorough knowledge of grant preparation, application, management, reporting, and federal guidelines.
- Thorough knowledge of federal and local regulations and policies governing the conduct of human clinical research (IRB and HIPAA policies).
- Ability to organize and retrieve documents required for regulatory and compliance requirements.
- Knowledge of clinical trial agreements and contracting procedures.
- Knowledge, skills and abilities in Concur, Info Ed, OnCore, and DAIDS data management systems.
- Skills in clinical research site management and writing standard operating procedures.
- Ability to prepare budgets and monitor expenditures using EPIC and OnCore systems.
- Ability to communicate effectively both orally and in writing.
- Highly proficient computer skills.
- Ability to establish work priorities, delegate assignments as appropriate, and follow through to ensure completion of activities.
- Ability to coordinate financial and administrative activities with other institutional departments, agencies and employees in order to meet the objectives of the grant.
- Ability to communicate and coordinate services with hospital scheduling services, billing office and specialized clinics (CTRC and Infectious Diseases).
- Knowledge of UPI billing practices and ability to verify UPI research related charges for payment.
Job Category: Faculty
Primary Location: Aurora
Posting Date: Apr 7, 2021
Unposting Date: Ongoing