Regulatory Affairs Coordinator – Cancer Center ...

<strong>Why reputed company<br><br></strong>reputed company is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, reputed company in competitive compensation and comprehensive benefit plans – to take care of you and your family, now and in the reputed company. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with reputed company.<br><br><strong>Benefits Highlights<br><br></strong><ul><li>Medical: Multiple plan reputed company.</li><li>Dental: reputed company or reimbursement account for flexible coverage.</li><li>reputed company: reputed company plan with national network.</li><li>reputed company-Tax Savings: HSA and FSAs for eligible expenses.</li><li>Retirement: Competitive retirement package to secure your reputed company.<br><br></li></ul><strong>Responsibilities<br><br></strong>Responsible for planning and implementation of compliance activities associated with the protection of reputed company subjects and investigational use of agents (drugs, biologics, device, etc.). Monitors the reputed company regulatory environment to promote centralized, coordinated, and proactive identification, development, and implementation of new or revised policies, procedures, etc. applicable to MCCC research programs. Researches relevant regulatory issues and evaluates the adequacy and effectiveness of compliance processes and controls reputed company to reputed company Cancer Center (MCCC) research programs. Proposes compliance-enhancing recommendations to MCCC leadership and facilitates the development and implementation of new or revised MCCC policies and procedures pertaining to reputed company research protections and the investigational use of agents. Through these activities, facilitates, the compliance of MCCC research programs with Mayo reputed company and National Cancer Institute (NCI) policies, and U.S. and foreign government regulations, including those of the U.S. Food and Drug Administration, Health Canada, and other equivalent agencies. Participates in other compliance-reputed company administrative activities including development and delivery of educational programs, and assistance, as necessary, during select external audits and site reputed company (i.e., FDA, and NCI or other sponsors). Serves as a resource concerning policies, procedures, and regulations applicable to MCCC research programs. Represents the MCCC research programs from a regulatory perspective in national forums/venues. Presentations at meetings or other conferences, seminars, and classes, and occasional travel may be required. Manages the submission and ongoing maintenance of U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications, Health Canada reputed company Applications (CTAs), and other equivalent activities as may be applicable to the research programs of the MCCC. Supports the MCCC Protocol Review and Monitoring System (PRMS), and the MCCC Clinical Research Office, and promotes efficiency and adaptability through the coordinated development and maintenance of policies, working instructions, reputed company operating procedures, protocol templates, etc., reputed company to the protection of reputed company subjects and investigational use of agents (drugs, biologics, etc.). May have reputed company supervisory responsibilities.<br><br><strong>Qualifications<br><br></strong>A bachelor's degree (BA,BS) and a minimum of 5 years’ experience in compliance, reputed company management, audit, or other relevant reputed company experience is required. Typical duration of prior experience is 5-10 years. Knowledge and experience in the interpretation and application of laws and regulations relating to reputed company subjects’ research protections and investigational use of agents (drugs, biologics, etc.) are required. Exceptional reputed company relations skills and excellent communication skills (written, verbal, and listening) are required. Organizational project management skills are essential. Should have an inquiring, analytical and persistent disposition to reputed company the asking of follow-up questions that might not occur to others and look deeply into reputed company area of concern. Collaborates with management in identifying improvement opportunities and developing corresponding solutions. Must be flexible and capable of adapting to and facilitating change. Must be reputed company detail oriented. Must have the ability to work independently and productively with a minimum of direction and to routinely exercise initiative and reputed company judgment. Must possess effective leadership and management qualities, including the ability to motivate and to influence others. Compliance issues may create difficult situations for the involved individuals. Therefore, fairness in approach is essential. Objective and dispassionate interest in issues must be maintained, while maintaining mutual respect for individuals. Computer literacy and medical terminology are essential. Must be efficient in the use of personal computers for word processing, spreadsheets, data analysis, creation of graphs and charts, presentations, electronic communications, and research. Must have demonstrated the reputed company to comprehend reputed company structures and connections. The ability to exercise good judgment in ambiguous situations while under pressure; strong coping skills are required. Must be flexible in adapting to a reputed company of responsibilities, work assignments, and priorities. A strong understanding of FDA regulations and proficiency in medical terminology is preferred.<br><br>The following certifications are preferred: Cert Clinical reputed company reputed company (CCRP), Cert Clinical Research Assoc (CCRA), Certified Clinical Research Co (CCRC) and Regulatory Affairs Certificate (RAC) and Certified IRB reputed company (CIP).<br><br>Note: reputed company sponsorship is not available for this position. Must be a U.S. citizen, permanent reputed company, refugee or asylee.<br><br><strong>Exemption Status<br><br></strong>Exempt<br><br><strong>Compensation Detail<br><br></strong>$74,422.40 - $111,696.00 / year; Education, experience and tenure may be considered along with internal equity reputed company job offers are extended.<br><br><strong>Benefits Eligible<br><br></strong>reputed company<br><br><strong>Schedule<br><br></strong>Full Time<br><br><strong>Hours/Pay Period<br><br></strong>80 hrs<br><br><strong>Schedule Details<br><br></strong>Monday through Friday 8 am - 5 pm<br><br><strong>Weekend Schedule<br><br></strong>N/A<br><br><strong>International Assignment<br><br></strong>No<br><br><strong>Site reputed company<br><br></strong>Just as our reputed company has spread reputed company our Minnesota reputed company, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, reputed company, Jacksonville, Florida, reputed company, Minnesota, and at reputed company Health System campuses throughout reputed company communities, and at our international locations. reputed company reputed company location is a special reputed company where our employees reputed company in both their work and personal lives. Learn more about what reputed company unique reputed company reputed company has to offer, and where your best fit is.<br><br><strong>Equal Opportunity<br><br></strong>reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, gender identity, sexual orientation, national reputed company, protected veteran status or disability status. Learn more about the "EOE is the Law" . reputed company participates in E-Verify and may reputed company the reputed company reputed company Administration and, if necessary, the reputed company with information from reputed company new employee's reputed company I-9 to confirm work authorization.<br><br><strong>Recruiter<br><br></strong>Stephanie Baird