Regulatory Facilitator

Location
Aurora, CO
Posted
Aug 10, 2018
Institution Type
Four-Year Institution


University of Colorado Denver l Anschutz Medical Campus
Office of Regulatory Compliance / Clinical Research Support Center
Job Title: Regulatory Facilitator
Position #703883 - Requisition #14404

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


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.

Who We Are:
CU Anschutz
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.

The Office of Regulatory Compliance has an opening for a full-time University Staff (unclassified) Regulatory Facilitator position.

Jobs in this career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.

Professionals at the intermediate level are responsible for exercising discretion, analytical skill, personal accountability and responsibility in a wide range of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field.

At the intermediate level, duties may be more limited in scope and are performed with guidance and direction from other professionals.

Job Summary:
The UCD Clinical Research Support Center (CRSC) has been established in partnership with the Clinical and Translational Science Award Center (CTSA) within the Office of Regulatory Compliance. The mission of the CRSC is to assist investigators in the development, submission and approval and ongoing management of their human subjects research.

This position requires independent action, and the use of discretion and creativity within the limits of institutional, state and federal policies to facilitate the research mission of the University of Colorado. This position works extensively with individuals in all areas of the University and the UCD affiliates to further UCD's research mission.

Examples of Work Performed:
  • Assists investigators and all members of the research team in the overall management of clinical research protocol documents and activity involving initial submission of human subjects research
  • Provides regulatory guidance and direction to investigators and all members of the research team in order to ensure compliance with all internal, external and federal policies, including UCD and affiliates, FDA, OHRP, COMIRB, GCP, and regulations that apply to research involving human subjects
  • Provide support to the CRSC by advertising clinical research training opportunities; creating and publishing the CRSC newsletter; provide support to special task forces such as TIN and JUMPSTART
  • Provide support to UCD faculty related to clinicaltrials.gov
  • Demonstrates strong understanding and working relationship with UCD, UCD Affiliates, CTSA, UCH, Children's Hospital Colorado and federal agencies
  • Assist investigators in compiling the required regulatory documents for submission of human subjects research
  • Assists investigators in navigating the approval process of human subjects' research
  • Other duties as assigned
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.


Qualifications

Minimum Qualifications:
  • A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution
  • 1 year of professional level experience in clinical research
  • Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
PLEASE NOTE: Candidates will be responsible for travel expenses related to the interview process and any relocation expenses, if applicable.

Conditions of Employment:
  • Must be willing and able to sit and stand for long periods of time
  • Must be willing and able to lift and carry up to 25 pounds
Preferred Qualifications:
  • Three years of clinical research experience
  • Understanding of regulations that apply to research involving human subjects
  • Experience working with academic center regulatory processes as related to clinical trials
Competencies:
  • 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
  • Working knowledge and experience in a clinical and/or research setting with adult and pediatric populations, technology transfer and research administration
  • Experience and familiarity with FDA OHRP, GCP, ICH, PHS, NSF regulations, COMIRB Policy and Procedures and sponsor operating procedures
  • Knowledge of ethical concepts
  • Proficient in Windows, MS Word, Excel, SharePoint
  • Experience and significant participation in preparation of documents for human subject regulatory submissions
  • Demonstrates accuracy in all details, is able to record and report effectively
  • Ability to work independently, prioritize tasks, work under deadlines, effectively and with minimal supervision
  • Ability to coordinate multiple projects of varying complexity simultaneously and work efficiently to meet departmental and investigator timelines
  • Ability to effectively prepare and coordinate meetings
  • Experience dealing with highly confidential and sensitive personnel issues
Salary and Benefits:
  • The hiring range for this position has been established at $47,000 to $55,000 and is commensurate with skills and experience
  • 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: https://www.cu.edu/employee-services/total-compensation
Diversity and Equity:
  • Please click here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspx
  • 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.

Special Instructions to Applicants:Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references) Questions should be directed to: Molly Van Rheen - Molly.VanRheen@ucdenver.edu



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

Application Materials Instructions:Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Application Deadline: Review of applications will begin immediately and will continue until the position is filled.



Job Category: Research Services

Primary Location: Aurora

Department: H0001 -- Anschutz Medical Campus - 60065 - ADM-VCR-Reg/Compliance Office

Schedule: Full-time

Posting Date: Aug 9, 2018

Closing Date: Ongoing

Posting Contact Name: Molly Van Rheen

Posting Contact Email: Molly.VanRheen@ucdenver.edu

Position Number: 00703883

PI103792368

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