Apply on Employer Site

University of Miami Health System · 5 months ago

Regulatory Analyst 2

Miami, FL

Full-time

Onsite

Entry, Mid Level

2+ years exp

The University of Miami Health System is an academic medical center providing leading-edge patient care. They are seeking a Regulatory Analyst 2 to oversee regulatory submissions and ensure compliance with applicable regulations throughout the study process.

Health CareHospitalMedicalmHealth

Responsibilities

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

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

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

Qualification

Regulatory submissionsIRB policiesClinical trials knowledgeAttention to detailEffective communicationInterpersonal relationshipsStress managementInstruction followingCCRP certification