JOB DESCRIPTION: The Clinical Trials Regulatory Specialist I is an entry-level position supporting regulatory affairs in clinical trial research. The primary focus of the position is to collaborate with the multiple IRBs, sponsoring companies, and site Project Managers to ensure study documents receive committee approval and are made available to the site in a timely manner. This position will oversee pre-submission to governing agencies, and provide foundational information for more complex regulatory work. Incumbents in this job classification may be primarily focused on non-interventional studies, with a relatively small trial portfolio.
Duties include:
Assists regulatory team (Regulatory Specialist II and III) in research efforts by facilitating the protocol approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects. Supports processes and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board (IRB) policies and procedures and regulations. Responsible for study completion processes including data lock, study closeout, reporting and archiving of study files, ensuring completeness and continuity of all study data, performing ongoing checks of clinical/translational data that has been entered on the case report forms (paper or electronic) 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. In a timely fashion, monitors, detects and reports adverse events meeting requirements of regulatory bodies. Coordinates activities and gathers information from a variety of sources to achieve stated outcomes. Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, bio-sketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs. Performs protocol activation and assist investigators with NCI Registration and Credential Repository (RCR) tasks (i.e. new and renewals) Reviews initial submissions to determine review category and action to be taken. Compiles and maintains eRegulatory Binders Completes submission applications, and other required documentation, prepares protocol specific forms for submission to various review committees, including internal scientific review boards, the IRB and sponsoring entities. Supports the Assistant Director, Operations Manager, and Regulatory Coordinators II/III in Program Research in the day-to-day activities of regulatory safety management for patients enrolled on research protocols. Completes protocol renewal applications, amendment applications and maintains record of all adverse event reports. Attends research team meetings to report on regulatory issues. With department administration, develops and manages study budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance, providing reports to investigators, department administration and funding agencies. Performs related responsibilities as required.
MINIMUM QUALIFICATIONS: Bachelor's degree, or an equivalent combination of experience, education and training. Knowledge of clinical research practices. Must complete all required training courses within one month of hiring date. |
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Human Resources