Regulatory Analyst 1

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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Remote Regulatory Analyst 1.  

CORE JOB SUMMARY:

The SCCC department is seeking a Regulatory Analyst 1 that will be responsible for conducting the on-site audits, reviewing consolidated records (the results of the records once the new data are added), designing, reviewing and testing the revised treatment matrix which will identify possible cancers from claims data. The RA1 will facilitate the process of preparing required regulatory documentation for initial and subsequent study submissions to various boards, committees, industry, academic, and cooperative sponsors. Provides regulatory support for multiple clinical trials from study start-up through study closure. Generates and updates essential regulatory documents, accordingly, including the editing of consent forms appropriately based on required institutional language and/or study revisions.   Attends site visits conducted by sponsor/Contract Research Organization (CRO) for matters concerning regulatory documents. Maintains current knowledge of applicable regulatory topics (e.g., institutional SOPs, federal regulations, etc.) and adheres to university and department-level policies and procedures and safeguards University assets. Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH, and other applicable regulations.

CORE JOB FUNCTIONS:

• Analyzes regulatory requirements, identifying potential conflicts, and has thorough knowledge and ability to apply federal regulations and University policies.

• Oversees accurate and timely processing, tracking and filing of submissions to and actions which includes monthly notifications on submissions for federally mandated deadlines.

• Assists with drafting, preparation, and presentation of programs to investigators and their research staff to raise and maintain knowledge and awareness of research compliance.

• Provides support to investigators by reviewing submissions for content.

• Sends decision correspondence to appropriate parties requesting information.

• Maintains accurate databases generate letters, develops and maintains templates, creates files, and mailing notices.​

Develops and maintains templates, creates files, and mails notices. 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: Bachelor’s degree in relevant field

Experience:  Minimum 1 year of relevant experience

Any relevant education, certifications and/or work experience may be considered

Department Specific Functions

DUTIES & RESPONSIBILITIES:

Job duties will include, but not be limited to:

Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board (IRB) from study start-up 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 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 start-up throughout the completion of the study.

  • Initial IRB application
  • Amendments / modifications
  • Reportable new information
  • Protocol deviations / violations
  • Protocol exceptions
  • IND safety letters
  • Continuing and final reports
  • Other communications from the sponsor requiring IRB submission.
  • 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.
  • Maintains department credentialing information and research records for clinical trials within institution’s electronic systems (e.g., Velos, Complion) and appropriate drives, as applicable.
  • Participate in site visits with monitors as well as site audits concerning compliance of regulatory documents. Ensure timely resolution of observations identified during monitoring and auditing visits.
  • Communicate with Clinical 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.
  • Assist in the collection and maintenance of credentialing information for study personnel (e.g., study-specific training, IBC, EHS requirements, etc.).
  • Upkeep of departmental trackers with study updates to ensure study team personnel are effectively alerted of initial study approvals and IRB approved study and consent amendments.
  • Communicate to SCCC staff and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol, exceptions, continuing reports, and study modifications. This includes facilitation of training and notification of required re-consenting in collaboration with the clinical team following approval of study modifications.
  • Provides updates to the study team and/or management regarding submission statuses and approvals (e.g. initial and amendments) during internal team meetings and upon request.
  • Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email as well as provide submission updates upon request. This responsibility is sponsor dependent. The following documents may be included:
  • Financial Disclosure Forms
  • FDA 1572
  • Initial Protocol Signature Page
  • Amendments signature page
  • Investigators CV and Medical Licenses
  • Laboratories normal ranges and certifications
  • IRB approvals
  • Approved consents
  • Other documents as required by the sponsor
  • Provide feedback to Regulatory Management on opportunities for regulatory process improvement.
  • Identifies and escalates issues before they become critical.
  • Assists with various regulatory related projects under the direction of the Regulatory Manager and/or Director of Regulatory.
  • Other duties as assigned by senior management.

Education:

  • Bachelor’s degree
  • In lieu of bachelor’s degree, years of relevant experience in clinical research, compliance, research, or a medical setting may be substituted for the educational requirement.

Certification and Licensing:

  • Not required

Experience:

  • Minimum one (1) year of relevant experience in compliance, research, or a medical setting.
  • Experience in clinical trials is preferred.

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.

#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 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 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. We’re the challenge you’ve been looking for.

Patient safety is a top priority. As a result, during the Influenza (“the flu”) season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination. Failure to meet this requirement will result in rescinding or termination of employment.

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