DescriptionUniversity of Colorado- School of Medicine
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.Nature of Work:
This is a 100% FTE position for a Program Coordinator / Instructor for an active clinical research program in Genetics of Pulmonary Fibrosis study in the Interstitial Lung Disease (ILD) program at University of Colorado School of Medicine. This position will be supervised by Dr. Lee and work closely with an interdisciplinary team of collaborative investigators (Drs. Lee, Schwartz, and Yang) to help develop novel research programs within focused on understanding the causes of pulmonary fibrosis.This full-time position will primarily oversee the management of a team of study coordinators who are focused on the recruitment of subjects and families with pulmonary fibrosis, the acquisition of samples and radiographic studies, the collection of medical records, the follow up of study subjects and their families, and will work closely with the principle investigators to achieve the goals of the research. Supervision Received:
This position will report to the study principle investigators, will work with other collaborating investigators, and will manage a team of study coordinators.Supervision Exercised:
This position will supervise and provide training, as needed, to Sr PRAs and PRAs in the Genetics of Pulmoanry Fibrosis study in the ILD program.Areas of Responsibility
:1. Oversee and manage investigator initiated studies and research in pulmonary fibrosis
This position will help oversee and implement clinical research programs as part of a broad based program in pulmonary fibrosis. Specific activities will include:
Oversight and implementation of clinical research database and bioprepository for study subjects with, or at risk for, pulmonary fibrosisOversight and implementation of subject recruitment, screening, consenting, coordination of research visits/protocol procedures and data collectionLongitudinal data entry and maintenanceWork collaboratively with the laboratory based team of investigators and technicians to collecting, process and storing biological samples for researchAssist with human research component of research grant applicationsOverall compliance with the policy and procedures for conducting good clinical trials; ensurescompliance with FDA, OHRP, GCP, IRB, HIPAA, UCD and affiliatesConducting study visits for clinical research2. Research Regulatory Management
Knowledge, Skills, and Abilities:
- All regulatory activities required to implement and maintain the clinical research endeavors as part of the pulmonary fibrosis research program.
- Assist with clinical research budgeting and negotiations with PIs primary division
- Coordinate payment of study expenses, such as medical service fees, IRB fees and study subject payments with PIs primary division
- Development of SOPs for human research operation
- Participation in protocol meetings, trainings and audits
- Participate in meetings and training provided by UCD and affiliates, such as Research Advisory Forum (RAF) and education sessions
- Establish, update, and maintain all IRBs and provide human use data for grant renewals and proposal submissions
- Requires independent judgment as well as self-directed work capabilities.
- This position requires at least 5 years of extensive experience with managing multiple projects and someone who can effectively multi-task
- Ability to establish work priorities and handle multiple deadlines.
- Ability to handle sensitive and confidential information and documents and maintain strict confidentiality in all HIPAA matters
- Ability to plan, implement, and coordinate financial and administrative activities.
- Ability to work independently as well as part of a team.
- Ability to communicate effectively and professionally with patients, faculty and staff.
- Ability to use various computer systems and software applications.
- Ability to initiate and maintain effective lines of communication with other areas/departments/sponsors.
- Ability to supervise and integrate a team of coordinators.
- Demonstrated expertise and experience with IRB submissions
Salary and Benefits:
- Strong organizational skills and attention to detail essential.
- Demonstrated experience with creating and maintaining clinical research projects and clinical trials
- Ability to multi-task
- Experience with research database management (e.g. REDCap)
- This position requires a high level of proficiency with computers and use of Microsoft Excel, Outlook, Word, and other University and Departmental systems as required.
- Familiarity with FDA, OHRP, GCP, ICH and HIPAA regulations
- Demonstrated oversight and management of others
- Demonstrated experience and expertise in IRBs
The salary range (or hiring range) for this position has been established at $56,000 to $120,000. 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.The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at Employee Services
.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 checks for all new employees prior to their employment.The Immigration Reform and Control Act requires that verification of employment eligibility be documented for all new employees by the end of the third day of work. Alternative formats of this ad are available upon request for persons with disabilities.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-compensationDiversity and Equity:
Please click here for information on disability accommodations: https://www1.ucdenver.edu/offices/human-resources/employee-relations-performance/ada-compliance
Office of Equity: https://www1.ucdenver.edu/offices/equity
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.
- Master’s degree; equivalent combination of education and experience may substitute for degree.
- A minimum of five years of experience with coordinating and managing administrative and clinical research activities, preferably in a university research setting.
Applicants must meet minimum qualifications at the time of hireJob Category:
- Previous grant and/or contract experience preferred.
- Prior experience and expertise in study coordination.
- Prior management experience.
- Experience in budgets preparation and oversight
Mar 3, 2021Unposting Date: