Regulatory Analyst 2
Regulatory Analyst 2
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Job Description
Current Employees:
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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 2 to work at the UHealth medical campus in Miami FL.
CORE JOB SUMMARY
The Regulatory Analyst 2 - UHealth reviews prepares and provides oversight for initial and subsequent regulatory submissions from study start-up through study closure as well as the maintenance of regulatory documents to ensure compliance with applicable requirements and regulations.
CORE JOB FUNCTIONS
Oversee and provides support for the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for various boards committees and industry academic 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 raise awareness of research compliance. Maintains current knowledge of applicable regulatory topics (e.g. institutional SOPs federal regulations etc.). Ensures compliance of general and study specific regulatory related 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 all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
Education:
Bachelors degree in relevant field
Experience:
Minimum 2 year of relevant experience
Knowledge Skills and Attitudes:
- Skill in completing assignments accurately and with attention to detail.
- Ability to communicate effectively in both oral and written form.
- Ability to handle difficult and stressful situations with professional composure.
- Ability to maintain effective interpersonal relationships.
- Ability to understand and follow instructions.
DEPARTMENT ADDENDUM
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 able to assist with the following studies:
JOB FUNCTIONS:
Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (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 well 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 place from study activation throughout the completion of the study. Preparation and maintenance of regulatory binders (paper or electronic) with all necessary study documentation in compliance with institutional standard 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 all protocol-related training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within 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 related projects under the direction of the Manager of Regulatory
Department Specific Qualifications
Education:
Bachelors 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
The University of Miami offers competitive salaries and a comprehensive benefits package including medical dental tuition remission and more.
UHealth-University of Miami Health System South Floridas 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 academic 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 million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching research and patient care. Were the challenge youve been looking for.
The University of Miami 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 timeEmployee Type:
StaffPay Grade:
H9Required Experience:
IC
Employment Type
Full-Time
