Senior Regulatory Analyst
Job location: Miami, FL
Employment Type: Full-time
Posted data: 2021-03-26
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The University of Miami Has an exciting opportunity for a Senior Regulatory Analyst.
This individual will be responsible for assisting the Behavioral Community Shared Research (BCSR) of the Sylvester Comprehensive Cancer Center with submissions to the Protocol Review and Monitoring Committee (PRMC), IRB and other ancillary committees for all cancer related studies submitted for review. This individual will provide audit and support for the on-going quality assurance of research studies and activities, and will work closely with the PRMC staff, investigators and research staff to ensure adherence to institutional standards.
- Provide quality assurance/ regulatory support for new and ongoing research studies. Includes but not limited to correspondence with institutional and federal regulators, study file documentation creation and maintenance.
- Request and obtain the initial regulatory packet from the protocol investigator/sponsor or designated Clinical Research Organization (CRO), if applicable.
- Design, conduct, and coordinate the delivery of education and training programs for investigators, study coordinators, and staff performing any related research activities.
- Assist with development and quality control (QC) of new processes and standard operating procedures (SOPs).
- Develop small group training sessions to address areas of frequent research non-compliance as indicated by audit findings.
- Create, develop, and maintain a library of handouts, training materials, slide presentations, and manuals.
- Provide continuing quality control of research activities by reviewing research subject folders. Coordinate the entire process of pre-submission to the Protocol Review and Monitoring Committee (PRMC) including communicating with ancillary committees, study team, business office, and sponsors for document support but not limited to: Consent Form (s) Protocol Budget Contract IND Approval or Exemption Letter (if applicable) Investigator’s Brochure (if applicable) Patient documents (if applicable) Recruitment materials (if applicable) External DSMB charter (if applicable) Verify the following credentials for investigator(s) and study team member(s) listed on the PRMC Submission Form are current: Curriculum Vitae (CV) Medical License (as applicable) University of Miami Conflict of Interest (COI) Collobrative Institutional Training Initiative (CITI) Good Clinical Practice (GCP) Development and submission of IRB initial protocol. 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.). In addition, must follow the entire initial submission process until the new study is approved. Communication with study staff to ensure the maintenance and accuracy of the Delegation of Duties and 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.
- Attend required regulatory meetings for all BCSR study protocols.
- Organize and store protocol files including but are not limited to all protocol submission documents, correspondence from sponsor and study team, and responses/re-submissions.
- Communication with PI, study team and/or sponsor in order to organize and prepare the Protocol Response Letter for the Protocol Review and Monitoring Committee (PRMC) when required until final approval is granted. Assist investigators with the interpretation of regulations and UM Sponsored programs requirements for each study submissions.
- Assist managers with verifying adherence to audit response commitments and serve as the CAPA lead coordinator. Attend PSG meetings to provide regulatory updates and guidance.
- Perform other duties as assigned.
- Bachelor’s Degree required. Master’s degree preferred.
- Four years Regulatory Affairs experience in the research setting or equivalent combination of studies and relevant work experience inclusive of substantial experience in regulatory affairs.
- CCRP certified preferred. Strong organizational, analytic and communication skills.
- Knowledge of National Cancer Institute (NCI) guidelines in regards to PRMS and IRB policies and procedures, as well as industry regulations for clinical trials preferred.
- Ability to work well in a fast paced enviorment and manage multiple task simultaneously and independently. Familiarity with medical terminology and clinical research protocols including human subjects research applications.
- Proficiency with Microsoft Office products.
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.
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:c105