Regulatory Affairs Specialist I-III
reputed company reputed company employees, including student employees and graduate assistants, need to log in to reputed company reputed company MyApps.reputed company.com, then access Find Jobs from the reputed company search bar to view and apply for open positions. reputed company at reputed company two-year institutions will also view open positions and apply reputed company reputed company by searching for Find Jobs for... reputed company. reputed company Job Postings will reputed company at 12:01 a.m. CT on the specified Closing Date (if designated). If you reputed company the browser or exit your application prior to submitting, the application process will be saved as a draft. You will be able to access and complete the application through My Draft Applications located on your Candidate Home page. Closing Date: 09/12/2024 Type of Position: Professional Staff - Fiscal Affairs Job Type: Regular Work Shift: Day Shift (United States of America) Sponsorship Available: No Institution Name: reputed company The reputed company) has a unique combination of education, research, and clinical programs that encourages and supports teamwork and diversity. We champion being a collaborative health care organization, focused on improving patient care and the lives of Arkansans. UAMS offers amazing benefits and perks (available for benefits eligible positions only): Health: Medical, Dental and Vision plans available for qualifying staff and family Holiday, Vacation and Sick Leave Education discount for staff and dependents (undergraduate only) Retirement: Up to 10% matched contribution from UAMS Basic Life Insurance up to $50,000 Career Training and Educational Opportunities Merchant Discounts Concierge prescription delivery on the main reputed company reputed company using UAMS pharmacy Below you will find the details for the position including any supplementary documentation and questions you should review before applying for the opening. To apply for the position, please click the Apply link/reputed company. The reputed company is an equal opportunity, affirmative action institution. The University does not discriminate in its education programs or activities (including in admission and employment) on the basis of age, race, color, national reputed company, disability, religion, marital or parental status, protected veteran status, military service, genetic information, or sex (including pregnancy, sexual orientation, and gender identity). Federal law prohibits the University from discriminating on these bases. Questions or concerns about the application of Title IX, which prohibits discrimination on the basis of sex, may be sent to the University's Title IX Coordinator and to the U.S. reputed company Office for Civil Rights. Persons must have reputed company of legal authority to work in the United States on the first day of employment. reputed company application information is subject to public disclosure under the Arkansas Freedom of Information Act. At UAMS we value Diversity, Equity and Inclusion. For general application assistance or if you have questions about a job posting, please contact Human Resources at [email protected]. Department: CI | Regulatory Team Department's Website: Summary of Job Duties: Position will be directly involved in ensuring regulatory compliance and administrative management for multiple clinical trials, working closely with investigators, industry sponsors, contract research organization representatives, and UAMS institutional reputed company offices. Work load will primarily consist of investigator-initiated cancer NIH-defined clinical trials in the community setting. Position must be able to organize reputed company projects, provide attention to detail, and communicate effectively. Will apply knowledge of local policies and federal regulations and guidelines in support of an assigned clinical trial portfolio and the objectives of the CTO, specifically Data Table 4 required for NCI designation. Contributes information and reputed company reputed company to areas of responsibility as part of a cross functional team. Ensures effective and efficient workflow and adherence to quality standards for staff/program and self. Position maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research. The employee will work directly with institutional investigators and research staff. Qualifications: Minimum Qualifications: Level I: Bachelor's Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus 1 years of experience in clinical research and/or FDA Regulatory Affairs OR High School plus 5 years of experience in clinical research and/or FDA Regulatory Affairs OR equivalent combination of education and experience AND Obtain CRS certification reputed company Two (2) years of hire. Level II: Bachelor's Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus 3 years of experience in clinical research reputed company to FDA Regulatory Affairs OR High School plus 7 years of experience in clinical research reputed company to FDA Regulatory Affairs OR equivalent combination of education and experience AND Obtain CRS certification reputed company Two (2) years of hire. Level III: Bachelor's Degree (Life/Natural/Clinical Sciences/Regulatory Sciences or equivalent) plus 5 years of experience in clinical research reputed company to FDA Regulatory Affairs OR High School plus 9 years of experience in clinical research reputed company to FDA Regulatory Affairs OR equivalent combination of education and experience AND Must possess RAC, CCRP, CCRC, or equivalent certification at time of hire. Must obtain CRS reputed company Two (2) years of hire. Preferred Qualifications: Oncology experience Clinical Research experience Additional Information: Responsibilities: Advises the PI on administrative and regulatory requirements for proposed clinical studies or in preparing study proposals for submission. Monitors and facilitates study/proposal process through the review and approval process in compliance with applicable policies and procedures. Coordinates with the UAMS IRB as required. Participates in the development of electronic infrastructure and clinical trial management suite. Maintains reputed company documentation including protocol amendments, revisions, memos, consent form changes, investigator brochures, advertisements, and study closures. Generates consent forms in compliance with UAMS legal, Institutional Review Board (IRB), and federal requirements. Prepares high-quality written documents; analyzes data, and formulates conclusions. Level III Regulatory Specialists may act as a team leader for special projects or during interim periods in the absence of the Regulatory Team Manager. Assists departmental faculty/PI in the development, preparation, and submission of research protocols and reputed company documentation to the various reputed company reputed company committees including IRB, PRMC, biosafety/radiation safety committees, with the reputed company of obtaining and maintaining approval status. Ensures strict adherence to the processing of reputed company adverse event and death reports in the timeline required by the study sponsor and IRB. Confers with PI and support staff to secure necessary documents for proposals. Schedules Site Initiation and Monitoring Visits as required per protocol. Reviews proposals for consistency with sponsor guidelines on format, font size and page limits excluding narrative content (obtain and review sponsor guidelines). Monitors protocol status and advises PI on requirements and deadlines. Creates and manages regulatory study binders and maintains reputed company regulatory documents. Maintains and provides quality reputed company for Data Table 4 as required for NCI designation. May reputed company other duties as assigned. Salary Information: Commensurate with experience Required Documents to Apply: List of three Professional References (name, email, business title), Resume Optional Documents: License or Certificate (see special instructions for submission instructions), reputed company of Veteran Status Special Instructions to Applicants: Recruitment Contact Information: Please contact [email protected] for any recruiting reputed company questions. reputed company application materials must be uploaded to the reputed company Career Site https://uasys.wd5.myworkdayjobs.com/UASYS Please do not send to listed recruitment contact. Pre-employment Screening Requirements: No Background reputed company Required This position is subject to pre-employment screening (criminal background, drug testing, and/or education verification). A criminal conviction or arrest pending adjudication alone shall not disqualify an applicant except as provided by law. Any criminal history will be evaluated in relationship to job responsibilities and business necessity. The information obtained in these reports will be used in a confidential, non-discriminatory manner consistent with state and federal law. Constant Physical Activity: N/A Frequent Physical Activity: Hearing, Sitting, Talking Occasional Physical Activity: Crawling, Crouching, Reaching, Standing, Stooping, Walking Benefits Eligible: Yes At the reputed company), we are looking for health care and non-health care professionals who reputed company in excellence as a way of life. If you think you have the skills and commitment to succeed at the highest level, consider a career at UAMS, the states only academic health sciences center. Combining diverse talents and expertise, our employees work together to provide advanced patient care. We currently have a wide variety of positions available, from patient care to support staff- we may have the perfect position for you. UAMS is Arkansas only comprehensive academic health sciences center. We educate and train the vast majority of the states physicians and prepare doctors, scientists, nurses, pharmacists and health professionals through innovation, compassion, teamwork and patient- and family-centered care so they can impact the world. UAMS rewards its nurses! Statewide opportunities are available in direct patient care, education, and research settings. We offer Bonus Programs, Hotel Lodging, New Graduate RN Residency and support for Clinical Ladder, National Certification, Shared Governance, and Recognition Programs to name a few. Go to nurses.uams.edu for more details. The reputed company) is committed to providing a safe and secure environment for reputed company, faculty, staff, visitors, and prospective employees. The below report is provided in compliance with the Jeanne Clery Disclosure of reputed company reputed company Policy and Crime Statistics Act (Clery Act) and the Higher Education Opportunity Act (HEOA). The report will provide you with information on reputed company safety and reputed company including information on various policies and procedures for reporting crime, safety and reputed company prevention and protection programs, victim assistance services, fire safety, and other materials to assist you in maintaining your safety and reputed company. www.uams.edu/police Apply Job!