Research Site Regulatory Manager

Oversees the department and manages all regulatory aspects of clinical trials conducted at the Clinical Research Center (CRC).

Ensures regulatory compliance with FDA, ICH-GCP, and IRB regulations.

ESSENTIAL FUNCTIONS


* Oversee and guide regulatory document processes and regulatory-specific timeline requirements for each study; monitor against study progress timelines and ensure study activity complies with relevant processes; suggest and implement alternative solutions for regulatory issues identified and take corrective action when necessary.


* Supervise the development, collection, and filing of all essential documents associated with each clinical trial.


* Complete and manage the Institutional Review Board (IRB) processes, including the initial submissions, amendments/administrative changes, safety updates, advertisements, continuing reviews, final reports, and other related duties and submissions


* Responsible for creating and submitting consent forms to the IRB as needed, verifying the contents address site-specific requirements and concerns, tracking versions and submissions, maintaining and providing appropriate current information to the coordinators


* Share applicable trial-level safety updates, such as providing IND report copies to all study personnel, and maintaining related documentation and records


* Work with the clinical team to maintain appropriate training and delegation documentation for all staff associated with each trial.


* Oversee preparation, modification, filing, tracking, and long-term off-site archiving of regulatory documents for clinical studies by the Regulatory Specialists and the Administrative Assistant


* Assess regulatory resource needs and establish appropriate study goals; monitor ongoing resource needs against performance


* Oversee and coordinate with the Regulatory Specialists regarding daily interactions with Physicians and Coordinators to ensure the Regulatory Department is aware of the status, changes, or new developments in the studies.

Define appropriate actions and complete associated documentation as appropriate


* Coordinate the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments, and keep CTI management aware


* Attend Site Selection Visits, as needed, and provide necessary regulatory documentation for the determination of the site's qualifications for study participation


* Attend industry conferences/webinars as appropriate


* Develop processes, implement updates, and review current policies and practices issued by regulatory agencies


* Develop, implement, and review site Regulatory SOPs and update when appropriate


* Coordinate with other departments to achieve project goals


* Review regulatory publications to keep apprised of new regulatory developments


* Comply with Good Clinical Practices (GCPs), FDA regulation and ICH guideline...