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Posting Detail Information

Working TitleIRB Coordinator

Position LocationFort Collins, CO

Work LocationPosition qualifies for hybrid/in-office work

Research Professional PositionNo

Posting Number202500616AP

Position TypeAdmin Professional/ Research Professional

Classification TitleProf/Indiv Contrib II

Number of Vacancies

Work Hours/Week40

Proposed Annual Salary Range$58,000 – $77,110

Employee Benefits

Colorado State University is not just a workplace; it’s a thriving community that’s transforming lives and improving the human condition through world-class teaching, research, and service. With a robust benefits package, collaborative atmosphere, and focus on work-life balance, CSU is where you can thrive, grow, and make a lasting impact.

+ Review our detailed benefits information here. (https://hr.colostate.edu/wp-content/uploads/sites/25/2021/01/benefits-summary-afap.pdf)

+ Explore the additional perks of working at CSU here.

+ For the total value of CSU benefits in addition to wages, use our compensation calculator (https://hr.colostate.edu/total-compensation-calculator/) .

+ Lastly, click here for more information about why Fort Collins is consistently ranked in the top cities to live in (https://hr.colostate.edu/prospective-employees/our-community/) !

Desired Start Date

Position End Date (if temporary)

To ensure full consideration, applications must be received by 11:59pm (MT) on06/02/2025

Description of Work Unit

The Office of the Vice President for Research has overall responsibility for promoting and facilitating the research enterprise at Colorado State University. The Office of the Vice President for Research will enable the University, its faculty, staff, and students to emerge as a world-class research institution complementing our learning, service, and outreach missions. The Office of the Vice President for Research will lead the 21st Century Land- Grant mission of Colorado State University by fostering and supporting the research enterprise, promoting scholarship and artistry, instilling a culture of integrity, inclusion and diversity, and capitalizing on opportunities to address global challenges.

Colorado State University ( CSU ) is recognized as one of the premier research institutions and routinely ranks in the top of all American Universities in research expenditures. The university was established in 1870 as the land-grant institution for the State of Colorado. The University is committed to equity and inclusive excellence, setting the standard for public research universities in education, research, and engagement for the benefit of the citizens of Colorado, the United States, and the world. Student enrollment is approximately 34,000, and the University employs more than 7,200 staff including academic faculty, administrative professionals, and classified staff. As a premier land-grant university, CSU is addressing and solving the great global challenges of our time.

CSU is in the city of Fort Collins, a dynamic community with a population of approximately 165,000. Situated 65 miles north of Denver at the western edge of the Great Plains and at the base of the foothills of the Rocky Mountains, Fort Collins is a gateway to world-class skiing, hiking, fishing, climbing, and biking. With an average of 300 days of sunshine per year and low humidity, Fort Collins residents enjoy pleasant weather year-round. Indoor and outdoor activities are enjoyable in every season. Colorado has earned a worldwide reputation as an area that offers an unparalleled lifestyle, and Fort Collins represents the very best of Colorado with top award rankings from Forbes for Best Place for Business/Careers, Gallup Well Being Index for Healthiest Mid- Size City in America, CBS Money watch List of Top 10 Best Places to Retire, Outside Magazine Best Towns in America, among other select recognitions:http://www.fcgov.com/fcfacts

Position Summary

The IRB Coordinator will serve as a contact and resource for investigators, faculty, and staff at Colorado State University ( CSU ). The position provides technical and administrative coordination to help facilitate the review of research protocols involving human subjects. This position provides education and retains documentation of training as regulated federally and by CSU IRB policies. The IRB Coordinator facilitates the research review and approval process of biomedical, social, and behavioral research and maintains records for all research submitted and processed by the CSU IRB . Work is completed in accordance with the processes and procedures that ensure compliance with federal and state laws, regulations, institutional policies, and guidelines governing human research protections. Review level determination is done independently. Guidance to navigate these complex problems requires a thorough understanding of various policies (federal, state, and institutional) that govern human subjects research (e.g., 45 CFR 46).

In this capacity, the employee is key to the University’s research enterprise.

Pre-employment Criminal Background Check is required for new hires.

This position is a 12-month full-time appointment, based in Fort Collins, with the potential for flexible work arrangements. The VPR Office supports flexible work arrangements for employees, including limited teleworking privileges. Read more here:https://pts.colostate.edu/employee/telecommuting

The successful candidate must be legally authorized to work in the United States by the proposed start date. The Institute will not sponsor a visa for this position.

Moving expenses of up to $7500 may be considered for successful candidates.

Required Job Qualifications

+ B.A. or B.S. degree in biomedical, health science, or social science or related field is required.

+ 2+ years of IRB experience including knowledge of 45 CFR 46, aka the Common Rule.

+ Understanding of the operation of the Food and Drug Administration ( FDA ) and the Federal Office of Human Research Protections ( OHRP ). Experience conducting designated reviews and/or experience serving on an IRB committee.

+ Proficiency with computer software packages (Microsoft Office Suite) including word processing and IRB submission databases. (Kuali, eProtocol, InfoEd or IRBNet).

+ Excellent written communication skills.

+ Excellent organizational skills and the ability to prioritize multiple tasks.

+ Ability to interact with a variety of individuals including faculty, administrators, government officials, colleagues, and support staff.

+ Ability to work independently and demonstrate sound decision making.

+ Ability to handle difficult situations effectively and collegially.

+ Experience working effectively within a team to achieve shared goals

Preferred Job Qualifications

+ Knowledge of CSU’s or equivalent university’s compliance culture.

+ Experience with federally sponsored research.

+ Certified IRB Professional ( CIP ) or ability to obtain certification within 2 year of employment

+ Experience with submissions and corresponding with IRB’s.

+ Experience working with Huron’s Toolkit for IRBs.

Essential Duties

Job Duty CategoryIRB Workload Management

Duty/Responsibility

+ Contributes to all efforts regarding IRB protocol submission(s) under the direction of the Senior IRB Coordinator and ensures understanding by all stakeholders of the protocol review process.

+ Analyzes and interprets current and proposed federal and state regulations and interpretations related to IRB compliance and implements necessary changes, in direct coordination with committee Chair and other IRB administrative colleagues, and colleagues external to the department, such as the Biosafety Officer(s), the Director/Associate Director of the Office of Sponsored programs, and the Authorized Institutional Official.

+ Designs and implements accurate and efficient procedures for managing regulatory protocols, including initial reviews, renewals of all types, conditions on approvals.

+ Designs and conducts IRB training and develops educational materials to provide the CSU community, including faculty, administrators, executives, students, and staff with the materials needed to understand current and historical trends of CSU’s human subjects’ research.

+ Receives and reviews protocols for administrative aspects; determines appropriate level of review. Reviews responses for responsiveness to committee requirements and routes for required actions.

+ Convenes meetings and ensures recording of accurate minutes. Post-meeting duties include execution of committee decisions by modification of policy documents and correspondence with researchers to convey determinations about protocols and facilitate corrective actions.

+ Maintains accurate and complete paper and electronic records, and assures the records are accessible upon request.

+ Demonstrates attention to detail and strong critical thinking skills, decision-making and strong organizational skills.

+ Consults with other campus offices on the status of specific projects and other administrative or technical matters, as well as in instances of reported campus violations and interpretation of new and existing procedures, policy, or regulation.

+ Maintains a professional and positive relationship with investigators and their staff, as well as IRB administrative colleagues.

Percentage Of Time50

Job Duty CategoryIRB Committee Oversight

Duty/Responsibility

+ Performs the duties below as directed by the IRB Manager.

+ Initiates and leads discussion, conversation, and communication related to CSU IRB functions.

+ Provides required IRB regulatory expertise for the committee.

+ At the direction of the IRB Manager guides committee operations re: compliance with federal and state regulations.

+ Works collaboratively with the IRB to convene monthly meetings, and direct protocols to IRB members for their review.

+ Serves as CSU’s IRB liaison, who is vital to ensuring representative members from the community who serve as IRB members

+ Coordinates the IRB meeting calendar and develops an agenda for regular committee meetings. Makes arrangements for extra meetings.

+ Secondary point of contact for reportable new information submissions, routes and tracks following department SOP’s.

+ Maintains a high level of discretion when working with sponsors, investigators, and other contacts, due to the confidential information and documents managed within the department.

+ Helps identify committee’s budget, space, resources, and training needs.

+ Maintains confidentiality regarding committee and sensitive institutional matters.

Percentage Of Time30

Job Duty CategoryQuality Improvement/ Quality Assurance

Duty/Responsibility

+ As needed, serves as liaison between CSU and the federal agencies on routine regulatory matters.

+ Assists in the negotiation of institutional assurances with the federal oversight offices.

+ Prepares (or assists in preparation of) other documents, such as annual reports, rosters, and registrations in a timely way.

+ Works in collaboration with the direct supervisor in preparations for government agency inspections of Committee’s operations.

+ May be asked to meet with auditors to represent the University’s position on regulatory matters, convey agency determinations to the committee and the VPR , or oversee the institution’s timely and documented response.

+ Maintains FDA audit readiness and OHRP human subject research audit readiness.

Percentage Of Time15

Job Duty CategoryProfessional Development

Duty/Responsibility

+ Participate in professional conferences, PDI training and other related programs that support CSU research quality.

Percentage Of Time5

Application Details

Special Instructions to Applicants

To apply, please upload a cover letter that addresses the required and preferred job qualifications, a resume, and the contact information for three professional references.

CSU is committed to full inclusion of qualified individuals. If you are needing assistance or accommodations with the search process, please reach out to the listed search contact.

References will not be contacted without prior notification to candidates. Please note, applicants may redact information from their application materials that identifies their age, date of birth, or dates of attendance at or graduation from an educational institution.

Conditions of EmploymentPre-employment Criminal Background Check (required for new hires)

Search ContactCami Lind, [email protected]

EEO

Colorado State University ( CSU ) provides equal employment opportunities to all applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Background Check Policy Statement

Colorado State University strives to provide a safe study, work, and living environment for its faculty, staff, volunteers and students. To support this environment and comply with applicable laws and regulations, CSU conducts background checks for the finalist before a final offer. The type of background check conducted varies by position and can include, but is not limited to, criminal history, sex offender registry, motor vehicle history, financial history, and/or education verification. Background checks will also be conducted when required by law or contract and when, in the discretion of the University, it is reasonable and prudent to do so.

References Requested

References Requested

Minimum Requested3

Maximum Requested3

Supplemental Questions

Required fields are indicated with an asterisk (*).

Applicant Documents

Required Documents

+ Cover Letter

+ Resume

Optional Documents