To us, it's about living life to the fullest while serving our patients, teammates, neighbors and friends. We are dedicated and passionate in everything we do, seeking challenge and appreciating the routes that got us here. Whether our path is clinical or not, we all came to find balance and meaning in our lives within the work we are passionate about and the adventures we live.
Vail Health has become the world’s most advanced mountain healthcare system. Our updated 520,000-square-foot hospital opened in December 2020. This state-of-the-art facility provides exceptional care to all of our patients, with the most beautiful views in the area, located centrally in Vail.
Some roles may be based outside of our Colorado office (as stated in the Job Title). Roles based outside of our primary office can sit in any of the following states: AZ, CO, CT, DC, FL, GA, ID, IL, KS, MA, MD, MI, MN, NC, NJ, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI. Please only apply if you are able to live and work full-time in one of the states listed above. State locations and specifics are subject to change as our hiring requirements shift. Pay is based upon relevant education and experience.
Description of job: Coordinates the administrative duties for daily operations of the Vail Health's Institutional Review Board (VH IRB) in accordance with regulatory requirements. Responsible for the management of applications submitted for IRB review and demonstrates sound judgment, as well as analytical, organizational, and time management skills. Serves as a critical link between and is an expert resource for the research community (principal investigators and other study personnel), the Vail Health IRB, and Vail Health IRB members.
1. Knowledgeable about the federal and state regulations governing human subject research, and related institutional policies and procedures; Attend seminars, workshops and conferences in order to gain insight into new trends in human research and to learn new approaches for the application of federal regulations.
2. Continuously interprets and applies the regulations and requirements to human subject research proposals and ongoing research activities.
3. Performs detailed analysis of all applications submitted for IRB review; manages the disposition of items submitted electronically for IRB review. This includes assessments of completeness, accuracy, and level of review required.
4. Provides technical support during convened IRB meetings; documents application-specific findings and generates investigator notifications regarding the outcome of the review.
5. Applies strong organizational skills and effective teamwork skills to manage a large volume of submissions, deadlines, and customer expectations; completes critical and comprehensive review of submissions, seeks clarification or modification of the submission from researchers, and makes independent determinations or presents recommendations to the convened IRB.
6. Serves as a voting member of the convened IRB and a designated Expedited Reviewer to review and approve non-exempt minimal risk research using expedited review procedures.
7. Exercises the authority to make exempt determinations; responsible for conducting evaluations of investigator's response to identify potential issues for IRB reviewers and advise as to whether the requirements for IRB approval have been met.
8. Responsible for managing the pre-meeting, meeting and post-meeting activities of the convened IRB. This includes agenda management, and meeting facilitation and documentation.
9. Participate in, or present at, research-related education sessions.
10. Evaluate reports of unanticipated problems, amendments and continuing review forms, and prepare recommendations to the committee. Report non-compliance issues to the IRB Director.
11. Assists IRB Director with regulatory, administrative and other operational matters as requested.
12. Role models the principles of a Just Culture and Organizational Values.
13. Perform other duties as assigned. Must be HIPAA compliant.
-Ability to efficiently manage 100+ protocols while maintaining a high degree of accuracy and attention to detail;
-Strong organization and decision making skills, the ability to judge and critique multiple issues, and the analytical skills necessary to apply knowledge of federal regulations and institutional policy to a variety of complex situations and research protocols;
-Strong interpersonal skills are needed to interact with a wide variety of persons related to human subject research. Ability to communicate with team members and others in a positive and effective manner;
-Use effective communication skills to facilitate convened IRB meetings; written communication skills in writing detailed, clear, precise and grammatically correct letters, minutes, correspondence, and reports;
-Dependable, self-directed, and willing to take the initiative for organizing own work to meet deadlines; ability to work independently and as a member of a team. Self-motivated to function independently in a high intensity environment often driven by deadlines. Know when to refer issues to Supervisor and have the ability to make accurate and appropriate independent judgments, but be able to accept direct supervision.
-Experience in designing, operating and implementing electronic IRB applications.
-Must possess discretion and mature judgment as confidential information is routinely encountered.
-At least 2 years experience in research administration and/or IRB experience in a health care environment.
One of the following certifications is preferred:
Certified IRB Professional (CIP)
Certified IRB Manager (CIM) certificate
Bachelor's degree required, preferably in a biomedical field, nursing, management or other health-related profession. Alternately, applicants with an Associate's degree and 6 years of experience may be considered. A Master’s degree is preferred.
Vail Health is a nonprofit community health care system serving patients and guests from around the world. Locally operated and governed by a volunteer board of directors, Vail Health includes a 56-bed hospital, accredited by the Joint Commission. Our 24/7 emergency department in Vail is a Level III Trauma Center with an onsite helipad for necessary medical transports.
Vail Health provides a wide array of services and access points including Colorado Mountain Medical, Beaver Creek Medical Center, urgent care clinics in Vail, Avon and Eagle, Edwards medical campus, Eagle Healthcare Center and a multispecialty clinic in Frisco. Howard Head Sports Medicine offers physical therapy services at 10 locations and works closely with our internationally renowned orthopaedic partners at The Steadman Clinic and Vail-Summit Orthopaedics & Neurosurgery. In addition, Vail Health's Shaw Cancer Center and Sonnenalp Breast Center are the region’s only fully accredited cancer treatment center and comprehensive breast center.
The Vail Clinic, which was founded in 1965, officially became “Vail Valley Medical Center” in 1980, its first year as a full-service hospital. At that time, we had one p...rimary location and 25 physicians. Today, Vail Health includes the hospital in Vail as well as affiliated service locations in 12 towns throughout Eagle and Summit counties, over 1,300 employees, 460 credentialed physicians, and around 90 volunteers.
Vail Health is an equal-opportunity employer. The hospital is handicap accessible and adheres to the Americans with Disabilities Act. Our health care system properties are officially smoke-free and tobacco-free. That means smoking cigarettes, e-cigarettes and vaping are prohibited in all areas of our campuses.
