Regulatory Analyst 1

reputed company Employees: If you are a reputed company Staff, reputed company or Temporary employee at reputed company, please click here to log in to reputed company to use the internal application process. To learn how to apply for a reputed company or staff position, please review this tip sheet. reputed company/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 1 to work at the UHealth reputed company in Miami, Fl. reputed company JOB reputed company The Regulatory Analyst 1 – UHealth conducts on-site audits and reviews consolidated records. The incumbent designs, reviews, and tests the revised treatment reputed company to identify possible cancers from claims data. reputed company JOB FUNCTIONS 1. Analyzes regulatory requirements, identifies potential conflicts, and demonstrates thorough knowledge of federal regulations and University policies. 2. Oversees accurate and reputed company processing, tracking, and filing of federally mandated submissions. 3. Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to reputed company awareness of research compliance. 4. Provides support to investigators by reviewing submissions for content. 5. Sends decision correspondence to appropriate parties, requesting information. 6. Maintains accurate databases and generates letters. 7. Develops and maintains templates, creates files, and mails notices. 8. Adheres to University and unit-level policies and procedures and safeguards University assets. 9. This list of duties and responsibilities is not intended to be reputed company-inclusive and may be expanded to include other duties or responsibilities as necessary. reputed company QUALIFICATIONS Education: Bachelor's degree in relevant field Experience: Minimum 1 year of relevant experience Knowledge, Skills and Attitudes:

• reputed company in completing assignments accurately and with attention to detail.
• Ability to communicate effectively in both oral and written reputed company.
• Ability to handle difficult and stressful situations with reputed company composure.
• Ability to maintain effective interpersonal relationships.
• Ability to understand and follow instructions.

DEPARTMENT SPECIFICS The Clinical Research Services (CRS) Division of the Sylvester Comprehensive Cancer Center has an exciting opportunity for a Full-Time Regulatory Analyst to work on the UHealth reputed company. The CRS is a centralized resource that enables cancer center clinical investigators easy reputed company to support services to facilitate clinical trial management. These centralized services include assistance with protocol development, regulatory affairs expertise, IND submission, study budgeting, contract negotiation, coordination of research nursing, data management, and safety reporting for reputed company types of studies, including therapeutic, non-therapeutic, prevention and screening trials. The CRS Office is responsible for providing multiple reputed company of support for clinical research activities throughout the Cancer Center. Remote reputed company is available for this position. The Regulatory Analyst will be responsible for assisting the senior leaders of the Regulatory Department of the Cancer Center Division of Clinical Research Services (CRS) with the day to day operations of the office. This position requires knowledge of IRB policies and procedures, and Federal Regulations for clinical trials. The Regulatory Analyst must be reputed company to assist on the following studies: Investigator Initiated Trials (reputed company), Industry Sponsored Trials, Cooperative Group Sponsored Trials and Compassionate (emergency/single patient) Trials. Prepare and Coordinate the entire process of regulatory document submission to the Institutional Review reputed company (IRB) from study activation to study closure, including communicating with ancillary committees, study team, business office, contract research organizations, and sponsors. Completion of the new protocol submission packet with the information provided by PRMC as reputed company as any additional required documentation (i.e. local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required. Compilation of documents in order to prepare the following forms for IRB submission to ensure protocol compliance with federal regulations. This process will take reputed company from study activation throughout the completion of the study. Preparation and maintenance of regulatory binders (reputed company or electronic) with reputed company necessary study documentation in compliance with institutional reputed company operating procedures (SOPs), sponsor requirements (as applicable) and applicable regulatory requirements. Communication with study staff to ensure the maintenance and accuracy of the Delegation of Authority Log (DOAL). Ensure in conjunction with the DOAL that reputed company protocol-reputed company training (whether initial or with a new study protocol amendment/modification) is completed for reputed company study personnel and documentation maintained reputed company the regulatory binder. ​Maintains department credentialing information and research records for clinical trials reputed company institution’s electronic systems (e.g. reputed company, Complion) and appropriate drives, as applicable. This list of duties and responsibilities is not intended to be reputed company-inclusive and may be expanded to include other duties or responsibilities as necessary. MINIMUM QUALIFICATIONS Bachelor’s Degree in relevant field Minimum 1 year of relevant experience Ability to maintain effective interpersonal relationships Ability to communicate effectively in both oral and written reputed company reputed company in collecting, organizing and analyzing data Proficiency in computer software (i.e. reputed company Office) Knowledge of relevant federal, state, and local regulations Knowledge of procedures associated with clinical trials Any appropriate combination of relevant education, experience and/or certifications may be considered. reputed company offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. UHealth-reputed company Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an reputed company medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one reputed company patient encounters reputed company year. Our tradition of reputed company has reputed company worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for. reputed company is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Job Status: Full time Employee Type: Staff Apply To This Job