Regulatory Specialist

Summary

Join Profound Research, a company driving clinical innovation by partnering with community physicians, as a Regulatory Specialist. This remote, U.S.-based role supports and maintains the eRegulatory system, ensuring all study documents are properly filed and distributed. You will assist with study start-up documents, monitor IRB portals, and review regulatory documents. The position also involves supporting eRegulatory training, ensuring document communication, and contributing to trial conduct. Success requires experience with eRegulatory systems, proficiency in Microsoft Word and Excel, and GCP training. The role demands strong teamwork, attention to detail, and excellent communication skills.

Requirements

• Experience in /with clinical research strongly encouraged
• Experience with eRegulatory systems
• Proficient with Microsoft Word, Excel
• Training in GCPis required
• Strong focus on teamwork, attention to detail, excellent organizational and planning skills. Must be able to prioritize, excellent written and verbal communication skills, and work in a fast-moving environment
• Ability to respond appropriately to sponsor/CRO representative
• Maintain confidential information
• Ability to project a professional, friendly, and helpful demeanor
• Must be able to remain in a stationary position 90 % of the time
• Constantly operates a computer and other office productivity machinery, such as a copy machine, fax machine, printer
• Regular and punctual attendance
• Perform other duties not specifically listed in this job description as assigned by the primary and secondary supervisors
• Prolonged periods of sitting at a desk and working on a computer, standing and walking
• Must be able to lift 25 pounds at times
• Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling
• Talking: Expressing or exchanging ideas by means of the spoken word; those activities where detailed or important spoken instructions must be conveyed to other workers accurately, loudly, or quickly
• Hearing: Perceiving the nature of sounds at normal speaking levels with or without correction and having the ability to receive detailed information through oral communication and making fine discriminations in sound
• The worker is required to have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication of parts at distances close to the eyes

Responsibilities

• Support and maintain eRegulatory System
• Assist with the completion of study start-up documents (i.e. 1572, Financial Disclosure Form, IRB submission, site information sheet and other documents as needed)
• Upload and file correspondence as part of regulatory for each study
• Maintain and update regulatory documents throughout the duration of study until study close- out
• Follow standard operating procedures (SOPs)as assigned and per training matrix
• Maintain current knowledge of regulatory affairs and/or issues
• Report, monitor, distribute and maintain files for all safety information including investigational drug brochures, investigational new drug (IND) safety reports and serious adverse event (SAE) reports
• Posts regulatory documents including protocols, amendments, consent forms, SAEforms, etc
• Monitor daily IRB portals for all site study binders to ensure clinical research coordinators are aware of the release of IRB approved documents such as Protocol, Informed Consents, Investigator Brochures, etc
• Review all monitor confirmation letters and follow-up letters and assist lead clinical research coordinator in submitting timely responses
• Conduct periodic reviews of eRegulatory study binders to ensure that all binders are audit ready with required documents easily accessible and organized
• Support eRegulatory Training
• Review and ensure training completion on essential study documents according to Profound training guidelines
• Support Essential Document Communication
• Ensure all IRB approved documents are uploaded and distributed to Lead Coordinator and site staff such as Protocol Amendment, Informed Consent, and Subject Material, etc
• Maintain staff CVs and current credentials
• Reconcile monitoring letters and visits verifying receipt of monitor confirmation and follow-up letters
• Assist with the preparation of monitoring visits and ensure study documents have been uploaded and filed in eRegulatory platform
• Tracks expirations and retrieves current documentation for medical licensures, CVs, and laboratory accreditations
• Support Trial Conduct
• Follow procedures pertaining to each study as applicable to department
• Maintain regulatory calendar in Outlook for all site monitor/audit visits
• Work closely with Clinical Research Coordinator, Regulatory Department and QA department to ensure QA audit report issues are resolved
• Assist with audit and oversight visit preparation
• Attend Site Initiation Visit as needed, review study start-up documents and study logs collected at the time of visit, monitor visit and close out visit to facilitate with the use of eRegulatory system and help resolve any issues at the time of the visit
• Perform other related duties including study enrollment, subject visits, etc. as delegated by clinical operations leadership or Sr. Director of Regulatory