Clinical Research Pre-Award Professional

Location
Aurora, CO
Posted
Apr 06, 2017
Institution Type
Four-Year Institution



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



University of Colorado Denver l Anschutz Medical Campus

School of Medicine Department of Neurology

Clinical Research Pre-Award Professional (Research Services Professional)

Position #732532 - Requisition 09064

The University of Colorado Denver Anschutz Medical Campus is a public research university serving more than 18,000 students. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer more than 140 highly rated degree programs through 13 schools and colleges. The university receives over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at CU Anschutz in Aurora, Colo. a significant number of undergraduate and graduate degree programs are taught at CU Denver, our comprehensive campus in the heart of downtown Denver-one of America's most vibrant urban centers. CU Denver is located steps from the Denver Center for Performing Arts and the LoDo District affording our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets.

A national leader in health care and life sciences, CU Anschutz is the only comprehensive academic health sciences center in Colorado and the largest in the Rocky Mountain region. Located in Aurora, Colo., it is one of the newest education, research and patient care facilities in the world. With six schools and colleges, CU Anschutz trains the health sciences workforce of the future by blending education, research and clinical care all in one place. This strategic collaboration among diverse health care fields allows knowledge to travel directly from the research bench to the patient's bedside. Read CU Anschutz Quick Facts here.

The University of Colorado Anschutz Medical Campus ranks among the top institutions nationally in clinical care, education and research. Its 230-acre campus, designed to enhance collaboration and interprofessional education, hosts the College of Nursing; the Schools of Dental Medicine, Medicine, Pharmacy, and Public Health; the Graduate School; a Health Sciences Library; and two hospitals. Strategically located contiguous to the campus are a biosciences research park and the soon-to-be-completed Veterans Hospital. CU Anschutz offers two undergraduate degrees, 35 graduate degrees, and five first-professional programs. More than 4,000 students learn alongside faculty members who also make meaningful medical discoveries and provide expert clinical care through 1.5 million patient-visits annually. A hub for research and innovation, CU Anschutz receives over $400 million in research awards each year and has filed 1,300 patent applications and formed 53 new companies since 2002.

Job Summary:
The University of Colorado l Anschutz Medical Campus is seeking applications for a Clinical Research Pre-Award Professional. This full-time, University Staff (non-classified) position will assist faculty in the submission and pre-award administration of grants and contracts for the Neurology clinical trials research office. This includes primarily planning, organizing, and managing human subject project grant submissions and ensuring compliance with all internal and external policies and procedures that govern these projects. This position will assist with clinical trial budget creation and with Institutional Review Board (IRB) submissions and regulatory document completion.

Examples of Work Performed:
  • Responsible for the development, implementation and oversight of pre-award grant functions for all human subject research.
  • Ensure all contracts and applications follow sponsor and University guidelines and timelines and adherence to all grant and contract regulations and requirements.
  • Acts as a liaison with the Office of Grants and Contracts and UCHealth committees working on financial and resource utilization issues during study start-up and throughout life of the clinical trial project.
  • Prepares sponsor and institutional forms prior to submission deadlines to include compliance documentation, sub-recipient agreements, scope of work documents, and budget justifications.
  • Prepares funding source budget templates based on predetermined grant budgets utilizing compensation rates, fringe benefit rates, and approved escalation rates. Assists in advising PI and of any budget restrictions.
  • Advises Principal Investigator on funding source instructions regarding the grant budget, application, and allowable costs.
  • Keeps updated on any application instruction changes for federal sponsors.
  • Manages grant application submissions, contract routing as well as any subcontract agreements for all clinical trial projects.
  • Creates databases, tracks and updates accordingly, for PI Biosketches, CV's, Other Support documents, and all CITI trainings.
  • Assists the PI's with IRS Determination Letters and Letters of Support.
  • Interacts with PI's on clinical trial grants and contracts to ensure all submission deadlines are met.
  • Develops a comprehensive grants calendar that includes all clinical trial grant start, end and renewal dates.
  • Maintains the clinical research grant/contract information in the Project Tracking database.
  • Communicates with faculty on all issues related to the submission and routing of human subject research.
  • Assists the Development Manager with disseminating funding opportunities and updating PI's with status of funding and award notices.
  • Assists with post-award duties for all clinical trial projects regardless of funding source.
  • Creates, maintains, and updates process maps for all pre-award processes.
  • Assists the Regulatory Manager with IRB submissions and regulatory document completion.
  • Assists with budget creation and negotiation for industry-sponsored clinical trials.

Salary and Benefits:

The hiring salary for this position is commensurate with skills and experience. 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 https://www.cu.edu/employee-services.

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.

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 in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
  • One (1) year of budget development, grant and/or contract experience.

Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis, but not the specific experience.

Preferred Qualifications:
  • Two (2) years of clinical research coordination experience.
  • Experience working as part of a multidisciplinary team.
  • Experience working with human subject research regulations.
  • Experience coordinating clinical research studies and reading clinical trial protocols.
  • Previous clinical trial budgeting, grant and/or contract experience.
Competencies/Knowledge, Skills, and Abilities:
  • Thorough understanding of UCD fiscal policy and the regulations set forth by sponsoring agencies.
  • Ability to change and/or develop departmental policies to ensure the department(s) is within compliance.
  • Independent judgment as well as self-directed work capabilities.
  • Ability to learn the University's InfoEd system and procurement related functions.
  • Ability to interact with faculty, sponsors, PRAs, trainees, and the administrators on a regular basis. Communication will be across departmental and central administration lines.
  • Professional business conduct and an ability to maintain effective lines of communication are required.
  • Ability to prioritize and handle multiple competing deadlines is a must.
  • Proficient knowledge of Microsoft Excel and Word.
  • Individual must be very well organized, detail oriented, and able to work independently.
  • Working knowledge of human subject research regulations and experience coordinating clinical research studies and reading clinical trial protocols.


Special Instructions to Applicants:*Applications are accepted electronically ONLY at www.cu.edu/cu-careers.* REQUIRED APPLICATION MATERIALS: 1). A letter of application which specifically addresses the job requirements and outlines qualifications. 2) A current resume/CV. 3) List of 5 professional references. Questions should be directed to Donna Wilber at Donna.Wilber@ucdenver.edu

Reference checks are a standard step in our hiring process. You may be asked to provide contact information, including e-mail addresses, for up to 5 references if you are referred to the Hiring Authority for an interview. We will notify you prior to contacting both on and off-list references.

Application Materials Required:Cover Letter, Resume/CV, List of References

Application Materials Instructions:APPLICATION DEADLINE: Applications will be accepted until the position is filled, but full consideration will be given to complete applications received by April 18, 2017.Those who do not apply by April 18, 2017 may or may not be considered.



Job Category: Research Services

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 20244 - SOM-Neurology

Schedule: Full-time

Posting Date: Apr 5, 2017

Closing Date: Ongoing

Posting Contact Name: Donna Wilber

Posting Contact Email: Donna.Wilber@ucdenver.edu

Position Number: 00732532

PI97443194