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The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Regulatory Analyst 3 to work at the UHealth Medical Campus in Miami, FL

CORE JOB SUMMARY
The Regulatory Analyst 3 - UHealth assists the Regulatory Manager and/or Director of Regulatory with the day-to-day operations related to study start-up activities and regulatory maintenance of study records.

CORE JOB FUNCTIONS

Acts as a mentor for new employees and assists in the development and improvement of the

department's mentorship program.

Assists with the training of all regulatory affairs personnel with regards to regulatory compliance.

Conducts regular internal Quality Control (QC) of open and enrolling protocols determined to be of

high risk to human subjects.

Tracks compliance because of QC activities, makes the appropriate corrections, and contributes

educational topics based on findings as well as other resources.

Collaborates with QC Team on the annual re-abstracting and case finding audit as well as any ad-

hoc quality control studies.

Assumes responsibility for new abstractor case reviews.

Participates in clearing edits required for submitting data to state data exchange partners.

Collaborates in the audit response and CAPA processes to identify, recommend, and implement

corrective and preventive actions for regulatory with the guidance of senior leadership.

Assists in the creation and maintenance of policies and procedures for the regulatory team as well

as the development of presentations and work instructions for training.

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: Bachelor's degree in relevant field

Experience: Minimum 5 year of relevant experience. Any relevant education, certifications and/or work experience may be considered.

Certification and Licensing:

Research Certification (e.g., SOCRA CCRP) 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

Ability to maintain effective interpersonal relationships

Ability to communicate effectively in both oral and written form

Ability to utilize sound judgment, analyze problems, provides solutions and makes decisions

Skill in collecting, organizing and analyzing data

Highly organized, proactive, and detail oriented

Excellent skills in time-management, prioritization and multi-tasking

Proficiency in computer software (i.e., Microsoft Office, Adobe Acrobat)

Ability to establish and maintain effective working relationships with diverse set of internal/external cross functional co-workers, managers and clients

Knowledge of processes associated with clinical trials

Knowledge of applicable federal, state, and local rules and regulations

Department Specifics:

Review protocol package for completion after PRMC approval has been granted to guarantee the following documents are included:

Protocol Document

Consent Form(s)

IND Approval or Exemption Letter (if applicable)

Investigator’s Brochure (if applicable)

Draft Budget (if applicable)

Clinical Trial Agreement (CTA)

Patient documents (if applicable)

Recruitment materials (if applicable)

External DSMB charter (if applicable)

Completion of the new protocol submission packet with the information provided by PRMC as well as any additional required documentation (e.g., local protocol, HIPAA forms, etc.). Modifying and standardizing consent forms for IRB submission is required. In addition, must follow the entire initial submission process until the new study is approved.

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 (if applicable)

Continuing and final reports

Other communications from the sponsor requiring IRB submission

Communication with PI and study team to organize and prepare submissions of Investigator Initiated protocols as well as expanded access/compassionate use cases to the various committees (e.g Protocol Review and Monitoring Committee [PRMC]), for approval prior to IRB submission. Assist PI in addressing communications from PRMC pertaining to the initial protocol, amendments, or other changes in 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 subsequent training (whether initial or with a new study protocol amendment/modification) is completed for all study personnel and documentation maintained within the regulatory binder.

Coordinate audits and site visits with monitors concerning compliance of regulatory documents. 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.

Conduct regular internal QC of regulatory records for open and enrolling protocols and/or protocols determined to be of high risk to human subjects.

Compile regulatory-related metrics for use by senior management.

Preparation and submittal of IND and/or IDE applications and annual reports to the FDA for institutional clinical trials.

Coordinate regulatory activities for multi-site institutional clinical trials under the guidance of Regulatory management.

Act as liaison between investigators, study team and sponsor/Contract Research Organization (CRO) for the completion and submission of regulatory documents.

Communicate to study team and PI relevant aspects of the regulatory process concerning IRB approval of initial protocol, exceptions, continuing reports, and study modifications. This includes notification of training and notification of required re-consenting.

Serves as mentor to other Regulatory Analysts (primarily Regulatory Analyst II) to foster development of regulatory knowledge, skills and abilities.

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.

Communicate with the sponsor and/or contract research organization for completion and submission of regulatory documents via inter-links, regular mail, or email. This responsibility is sponsor dependent. The following documents may be included:

Financial Disclosure Forms

FDA 1572 (if applicable)

Initial Protocol Signature Page

Amendments signature page

Investigators CV and Medical Licenses

Laboratories normal ranges and certifications (if applicable)

IRB approvals

Approved consents

Other documents as required by the sponsor

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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.

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.

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