MCCRN Regulatory Coordinator
Posting DetailsJob TitleMCCRN Regulatory CoordinatorRequisition NumberRE24944Working TitleRegulatory CoordinatorDepartment Name7H025:CANCER CENTER-CORE SUPPORTWork LocationLexington, KYGrade Level45Salary Range$44,762-73,861/yearType of PositionStaffPosition Time Status Full-TimeRequired Education
BSClick here for more information about equivalencies:http://www.uky.edu/hr/employment/working-uk/equivalenciesRequired Related Experience
7 yrsRequired License/Registration/Certification
Professional certification(s) in clinical research or project management: PMP – CAPM, PMP, SoCRA – CCRP, and/or ACRP – CCRC or CCRAPhysical Requirements
Repetitive motion, and exposure to PC screens. Sitting for long periods of time, and job related travel.Shift
Monday-Friday 8:00 am – 5:00 pm (40 hrs/wk); Occasional work outside Monday-Friday for special eventsJob Summary
The Markey Cancer Center is seeking a Regulatory Coordinator who will perform activities to support central operations of a network conducting multi-center studies. Position duties are specific to overall site, study & program regulatory coordination, data & regulatory compliance.
This includes: serving as a resource to investigative teams, regulatory document management, regulatory quality, contributing to network operations, facilitating site start-up, maintaining trial master file, network membership master files, facilitating study project teams, participating in network committees, assisting Study Chairs & Project Teams to assure the conduct and oversight of quality studies, as applicable interfacing with MCC SRFs and MCC CRO.
The MCCRN Regulatory Coordinator serves as the primary liaison to sites for regulatory management, ensuring data & regulatory compliance utilizing variety of quality methods including coordination, training, monitoring. Duties require application of CFR, ICH, SOPs.Skills / Knowledge / Abilities
MS professional programs, research databases, HIPAA, HSP, web.Does this position have supervisory responsibilities? YesPreferred Education/Experience
Bachelor’s degree with seven or more years related experience.Deadline to Apply10/27/2020University Community of Inclusion
The University of Kentucky is committed to a diverse and inclusive workforce by ensuring all our students, faculty, and staff work in an environment of openness and acceptance. We strive to foster a community where people of all backgrounds, identities, and perspectives can feel secure and welcome. We also value the well-being of each of our employees and are dedicated to creating a healthy place to work, learn and live. In the interest of maintaining a safe and healthy environment for our students, employees, patients and visitors the University of Kentucky is a Tobacco & Drug Free campus.
As an Equal Opportunity Employer, we strongly encourage veterans, individuals with disabilities, women, and all minorities to consider our employment opportunities.
Any candidate offered a position may be required to pass pre-employment screenings as mandated by University of Kentucky Human Resources. These screenings may include a national background check and/or drug screen.Posting Specific Questions
Required fields are indicated with an asterisk (*).
- * Please identify the professional certification(s) that you hold in clinical research or project management:
- PMP – CAPM, PMP
- SoCRA - CCRP
- ACRP – CCRC or CCRA
- One or more of the above
- None of the above
- * How many years’ experience do you have in clinical research?
- 3-5 years
- 5-7 years
- 7-9 years
- 9 or more years
- * Which of the following best describes your highest level experience using data or study management computer systems:
- Have worked with in-house developed study and data systems in the capacity of data entry and data management (i.e., Excel, Access).
- Have worked with one or more commercial study management or data systems in the capacity of data entry.
- Have worked with one or more commercial study management or data systems in the capacity of data entry and generating reports.
- Have worked with multiple study management or data systems in a data management or other lead role.
- * How many study regulatory files or multi-site regulatory master project files have you set-up, and simultaneously maintained?
- 10 or more
- * Describe your greatest challenge in assuring regulatory quality in clinical research and your specific efforts to generate results in regards to this challenge.
(Open Ended Question)
- * University of Kentucky HealthCare seeks to attract, develop and retain highly skilled and competent employees, to provide the best experience for every patient, every time. If selected for a position, do you agree to abide by the UK HealthCare Values of diversity, innovation, respect, compassion, and teamwork?
- * University of Kentucky HealthCare recognizes a set of values that guide us in our daily interactions. By applying for a position within UK Healthcare, you are indicating your commitment and expressing your agreement to our five values. These values are diversity, innovation, respect, compassion, and teamwork. Please choose one of the UK Healthcare values and give a specific example when you exhibited this quality in your professional experience.
(Open Ended Question)
- * Where did you first see this position advertised other than on UK's online employment system?
- Diverseeducation.com (Diverse Issues in Higher Education)
- HERCjobs.org (Higher Education Recruitment Consortium)
- A Colleague, Friend and/or Family Member
- None of the Above
- AUTM.net (Assoc. of University Technology Managers)
- KyBar.org (Kentucky Bar Assoc.)
- Cover Letter