Regulatory Analyst 2

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 using the Career worklet, please review this tip sheet. reputed company/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 2 to work at the UHealth medical reputed company in Miami, FL. reputed company JOB reputed company The Regulatory Analyst 2 - UHealth reviews, prepares, and provides reputed company for initial and subsequent regulatory submissions from study start-up through study closure as reputed company as the maintenance of regulatory documents to ensure compliance with applicable requirements and regulations. reputed company JOB FUNCTIONS reputed company and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as reputed company of contact for various boards, committees, and industry, reputed company, and cooperative sponsors. Submits or assists in the submission of applications for institutional clinical trials. Sends decision correspondence to appropriate parties, requesting information. Assists with the drafting, preparation, and presentation of programs to investigators and their research staff to reputed company awareness of research compliance. Maintains reputed company knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.). Ensures compliance of general and study specific regulatory reputed company processes with institutional SOPs, FDA, NIH, and other applicable regulations. Adheres to University and unit-level policies and procedures and safeguards University assets. 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 2 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 reputed company Department Specific Functions This individual will be responsible for assisting the senior staff of the Office of Regulatory Services (ORS) for Population Sciences and Cancer Disparity Behavioral and Community-Based Shared Research (BCSR) of the Sylvester Comprehensive Cancer Center 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 2 must be reputed company to assist with the following studies: JOB FUNCTIONS: 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, 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. Communicate with Research Coordinators and PIs to review and submit protocol deviations and amendments as part of the plan to resolve the deficiencies identified during the audit/monitoring visit. Provides updates to the study team and/or management regarding submission statutes and approvals (e.g. initial and amendments) during internal team meetings and upon request. Assists with various regulatory reputed company reputed company under the direction of the Manager of Regulatory Department Specific Qualifications Education: Bachelor's degree in any relevant field Certification and Licensing: CCRP if applicable Experience: Minimum 2 years of relevant experience Knowledge, Skills and Attitudes:

• 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.

#LI-YC1 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 - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information. Job Status: Full time Employee Type: Staff Pay Grade: H9 Apply tot his job Apply To this Job