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Posting Detail Information
Working TitleSenior IRB Coordinator
Position LocationFort Collins, CO
Work LocationPosition qualifies for hybrid/in-office work
Research Professional PositionNo
Posting Number202401280AP
Position TypeAdmin Professional/ Research Professional
Classification TitleProf/Indiv Contrib II
Number of Vacancies
Work Hours/Week40
Proposed Annual Salary Range$70,000 - $95,000
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, commitment todiversity, equity and inclusion (https://inclusiveexcellence.colostate.edu/about/) , 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) on09/01/2024
Description of Work Unit
Founded in 1870, Colorado State University is among the nation’s leading research universities and enrolls approximately 32,000 undergraduate, graduate, and professional students. Located an hour north of the Denver metro area, Fort Collins is a vibrant community of approximately 157,000 residents that offers the convenience of a small town with all the amenities of a large city. Fort Collins is situated on the Front Range of the Rocky Mountains with views of 14,000 foot peaks, and offers access to numerous cultural, recreational, and outdoor opportunities.
The mission of Research Integrity & Compliance is to protect the rights and the welfare of research participants, provide guidance on research integrity issues, promote the responsible conduct of research, and work with the university research review committees to ensure that research is conducted ethically and in accordance with applicable regulations and guidelines
Position Summary
The Senior Institutional Review Board ( 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 Senior 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 . An extensive understanding of human subject research regulations and federal guidance documents is critical. 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. In this capacity, employee is key to the University’s research enterprise.
Required Job Qualifications
B.A. or B.S. degree in biomedical, health science, or social science or related field is required.
5+ years of IRB experience including knowledge of 45 CFR 46, aka the Common Rule.
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).
Current CIP® certification.
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.
Ability to handle difficult situations effectively and collegially.
Preferred Job Qualifications
Ability to maintain confidentiality about committee and department matters.
Experience in the conduct of clinical trials or clinical trials management (federal or industry-sponsored).
Experience leading or supporting the review of complex, multi-stage research protocols, including those having collaborations among multiple institutions.
Experience with sIRB requirements and post approval monitoring.
Knowledge of CSU’s compliance culture
Familiarity with sponsored research
Diversity Statement
Reflecting departmental and institutional values, candidates are expected to have the ability to advance the Department’s commitment to diversity and inclusion.
Essential Duties
Job Duty CategoryIRB Office Management
Duty/Responsibility
Leads all efforts regarding IRB protocol submissions 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 the HRPP Director, committee Chair and other related administrative positions, such as the directors of OSP , COI , Biosafety, Export Control and the Authorized Institutional Official.
Provides guidance and resources for clinical research investigators and key personnel on the interpretation of human subject research activities and regulatory requirements.
Designs and implements accurate and efficient systems for managing regulatory protocols, including initial reviews, renewals of all types, conditions on approvals, post-approval regulatory requirements.
As needed serves as the liaison between CSU and the federal agencies on routine regulatory matters. Assists in the maintenance 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 other units who are engaged in clinical trials research ( OSP , CCTSI , Clinical Trials Unit at HPCRL , etc.) for ongoing compliance needs.
Works in collaboration with the direct supervisor in preparations for government agency inspections of the 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 HRPP Director, or oversee the institution’s timely and documented response.
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.
Assists in the design and implementation of electronic protocol submission and review systems.
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 and advise on regulations and procedural issues. Post-meeting duties include the 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. Schedules and participates in inspections. Maintains documentation of inspections and generates all post-inspection reports and correspondence in a timely manner.
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. Coordinates with the direct supervisor and/or Sponsored Programs on complex research projects involving other universities and research organizations to ensure issuance of necessary federally required documents documenting regulatory matters.
Maintains a professional and positive relationship with investigators and their staff, as well as colleagues.
Percentage Of Time50
Job Duty CategoryIRB Committee Oversight
Duty/Responsibility
Directs and guides IRB committee(s) on human subject regulatory matters.
Initiates and leads discussion, conversation, and communication related to CSU IRB functions.
Provides required IRB regulatory expertise for the committee.
Directs and guides committee operations re: compliance with federal and state regulations.
Works independently with the IRB Chairperson and in collaboration with the IRB to convene monthly meetings, and direct protocols to IRB members for their review.
Serves as a liaison to community members who serve as IRB members.
Manages the IRB meeting calendar and develops agenda for regular committee meetings. Plans for extra meetings or inspections as needed.
In coordination with and under the direction of the HRPP Director implements and follows all institutional policies and procedures.
Primary point of contact for reportable events, including potential protocol non-compliance.
Establishes committee’s resources, and training needs.
Maintains confidentiality about committee matters.
Communicates with the HRPP Director and Authorized Institutional Official and prepares draft letters regarding memberships, policies and program reviews.
High-level communication and communication with IACUC and IBC coordinators on issues related to human subjects research and protection.
Percentage Of Time30
Job Duty CategoryAudit Responsibilities
Duty/Responsibility
As needed serves as the 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 director in preparations for government agency inspections of the 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 , OHRP Audit readiness.
Percentage Of Time15
Job Duty CategoryPolicy and Professional Development
Duty/Responsibility
Conduct IRB office operations following Huron Toolkit policies and procedures.
In collaboration with, and at the direction of the HRPP Director, conduct routine quality assurance activities.
Participate in conferences, PDI training and other related programs that support CSU research quality.
Percentage Of Time5
Application Details
Special Instructions to Applicants
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.
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. 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 ContactKathy.Kioussopoulos@colostate.edu
EEO Statement
Colorado State University is committed to providing an environment that is free from discrimination and harassment based on race, age, creed, color, religion, national origin or ancestry, sex, gender, disability, veteran status, genetic information, sexual orientation, gender identity/expression, or pregnancy in its employment, programs, services and activities, and admissions, and, in certain circumstances, marriage to a co-worker. The University will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. Colorado State University is an equal opportunity and equal access institution and affirmative action employer fully committed to achieving a diverse workforce and complies with all Federal and Colorado State laws, regulations, and executive orders regarding non-discrimination and affirmative action. TheOffice of Equal Opportunity (https://oeo.colostate.edu/) is located in 101 Student Services.
The Title IX Coordinator is the Director of the Office of Title IX Programs and Gender Equity, 123 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-1715,titleix@colostate.edu.
The Section 504 and ADA Coordinator is the Director of the Office of Equal Opportunity, 101 Student Services Building, Fort Collins, CO 80523-0160, (970) 491-5836,oeo@colostate.edu.
The Coordinator for any other forms of misconduct prohibited by the University’s Policy on Discrimination and Harassment is the Vice President for Equity, Equal Opportunity and Title IX, 101 Student Services Building, Fort Collins, Co. 80523-0160, (970) 491-5836,oeo@colostate.edu.
Any person may report sex discrimination under Title IX to theOffice of Civil Rights, Department of Education (https://www2.ed.gov/about/offices/list/ocr/docs/howto.html) .
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