Research Associate Clinical II

University of Kentucky Equal Employment Opportunity/M/F/disability/protected veteran status. Posting Details Job Title Research Associate Clinical II Requisition Number RE30290 Working Title CRA II (Regulatory) Department Name 7H024:MCC - CLINICAL RESEARCH ORG Work Location Lexington, KY Grade Level 43 Salary Range $18.25-29.21/hour Type of Position Staff Position Time Status Full-Time Required Education BS Click here for more information about equivalencies: Required Related Experience 3 yrs Required License/Registration/Certification CERTIFIED Physical Requirements Requires handling of light-weight objects up to 10 pounds, sitting for long periods of time, some standing or walking. Shift Monday-Friday 8:00am-4:30pm(40hrs wk) ; occasional overtime may be required. Job Summary The Research Associate Clinical II ( CRA II) - Regulatory accepts research responsibility with guidance from the Principal Investigator(s) and the Clinical Trial Management Director. The CRA II-Regulatory is responsible for obtaining and coordinating data and other required information needed to fulfill all the regulatory requirements for protocols, including IRB submissions, informed consents, safety reports, and adverse event forms. This position will work mainly with the Investigator Initiated Trials (IIT's), but will also work with Industry and Cooperative. Maintain all regulatory records as per FDA regulations. Maintain trial management databases required for each protocol. Ensure accuracy and completeness of regulatory records and verify ongoing studies are completed in accordance with applicable FDA regulations. Will participate in site evaluation, initiation, monitoring and termination visits. Develop standard operating procedures for regulatory activities to improve compliance and efficiency. Will assist in protocol development. The individual in this position will be expected to have an understanding of how the different areas of specialization (regulatory, IRB , financial) work together in the management of clinical research studies and protocols. CRA II-Regulatory will be required to attain certification as a clinical research professional via an accredited body (e.g. Society of Clinical Research Associates ( SOCRA ) or Association of Clinical Research Professionals ( ACRP ). CRA II-Regulatory will be required to maintain this certification by completing the necessary continuing education requirements established by the accrediting body. IMPORANT : To be considered for this position you must fully complete the online application being sure to only put 1 job title for each place you work (multiple job titles for one employer must have separate entries), the # of hours worked per week and your ending salary. You will also be required to upload a cover letter, resume and as Specific Request 1, a copy of your SoCRA or ACRP certification. Given the COVID -19 pandemic, and the need to protect our university community including our students, staff, faculty and visitors, the University of Kentucky is requiring COVID -19 vaccination for all new hires prior to starting employment. Therefore, as of October 18, 2021, all new hires prior to their first day of employment must submit appropriate documentation showing, i) completion of the first vaccination against COVID -19, or ii) completion of the full vaccination series against COVID -19, or iii) approved exemption (medical contraindications or a sincerely held religious belief) through the formal exemption process from the COVID -19 vaccination requirement. For those employees who have completed the first vaccination against COVID -19 prior to their first day of employment, the second vaccination (if applicable) must be completed following the vaccination recommended schedule to be considered fully vaccinated. Skills / Knowledge / Abilities Planning & organization, communication(written & verbal), time management, Microsoft Office Suite, EPIC Does this position have supervisory responsibilities? No Preferred Education/Experience Bachelors degree, plus 3 years of clinical regulatory work Deadline to Apply 11/30/2021 University 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 (*). * 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? Yes No * 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) * Given the COVID-19 pandemic, and the need to protect our university community including our students, staff, faculty and visitors, the University of Kentucky is requiring COVID-19 vaccination for all new hires prior to starting employment. Therefore, as of October 18, 2021, all new hires prior to their first day of employment, must submit appropriate documentation showing, i) completion of the first vaccination against COVID-19, or ii) completion of the full vaccination series against COVID-19, or iii) approved exemption (medical contraindications or a sincerely held religious belief) through the formal exemption process from the COVID-19 vaccination requirement. For those employees who have completed the first vaccination against COVID-19 prior to their first day of employment, the second vaccination (if applicable) must be completed following the vaccination recommended schedule to be considered fully vaccinated. I understand that I will be obligated to comply with the new COVID-19 vaccination requirement prior to starting employment at the University of Kentucky. Yes No * Do you have a current SOCRA (Society of Clinical Research Associates) certification or ACRP (Association of Clinical Research Professionals) certification or are you eligible to obtain this by date of hire? Yes No * Please choose the answer that best describes your amount of paid, full-time experience working with IRBs, protocol submissions, and patient consents. None More than 0, up through 1 year More than 1 year, up through 2 years More than 2 years, up through 3 years More than 3 years * Describe your previous work experience with clinical research as a regulatory CRA. (Open Ended Question) * Please select the answer that best describes your years of paid, full-time experience in clinical research. none more than 0, up through 1 year more than 1 year, up through 3 years more than 3 years, up through 5 years more than 5 years * Where did you first see this position advertised other than on UK's online employment system? InsideHigherEd.com HigherEdJobs.com Diverseeducation.com (Diverse Issues in Higher Education) HERCjobs.org (Higher Education Recruitment Consortium) InsightIntoDiversity.com Latinosinhighered.com HospitalCareers.com Indeed.com LinkedIn.com Institute for Diversity in Health Management A Colleague, Friend and/or Family Member None of the Above Applicant Documents Required Documents Resume Cover Letter Specific Request 1 Optional Documents Equal employment opportunity, including veterans and individuals with disabilities. PI272420663