Regulatory Associate

Regulatory Associate Department: Study Management Position Summary: The Regulatory Associate position is responsible for providing support to the Regulatory Administrator through coordinating and documenting internal regulatory processes, such as internal audits, inspections, license renewals, or registrations across multiple studies. This position collaborates with multiple IRBs, sponsoring companies, and co-workers to ensure study documents receive approval and are made available to the site in a timely manner.

The Regulatory Associate will oversee pre-submission to governing agencies and provide foundational information for more complex regulatory work. This position reports to the Regulatory Administrator. Position

Responsibilities

: Assist the Regulatory Administrator in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial’s duration for research studies.

Supports processes and monitors practices to ensure regulatory documentation involving clinical trials complies with the Institutional Review Board (IRB) policies, procedures, and regulations Responsible for study completion processes including reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical data that has been entered on case report forms or in reports and assuring archival of appropriate/required documentation Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process Knowledgeable of the safety reporting

Requirements

of the study protocol, FDA and other regulatory bodies Monitors, detects, and reports adverse events meeting

Requirements

of regulatory bodies in a timely manner Coordinates activities and gathers information from a variety of sources to achieve stated outcomes Completes and maintains regulatory documents for all study personnel, including CVs, licenses, Form FDA 1572, confidentiality agreements, and delegation of duties logs Reviews initial submissions to determine review category and action to be taken Compiles and maintains Paper Investigator Site File (ISF) Binders and eISF.

Completes regulatory applications and other required documentation, prepares protocol specific forms for submission to various review committees, including review boards, the IRB, and sponsors Supports the Regulatory Administrator and VP of Study Operations t in the day-to-day activities of regulatory safety management for patients enrolled on research protocols Completes protocol renewal applications, amendment applications, and maintains records of all adverse event reports Attends research team meetings to report on regulatory issues Assists Regulatory Administrator in creating and maintaining protocol specific training documents Communicates with CRA at on-site and/or remote monitoring visits and assists with necessary regulatory tasks Other duties as assigned ATS provider: Paylocity.

Salary: USD.