Regulatory Affairs Assistant

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Full Time Regular Admin Support Miami, FL, US

6 days ago Requisition

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you! The Regulatory Affairs Assistant supports the preparation, organization, submission, and maintenance of regulatory documentation for clinical research studies. This position helps ensure that study records are complete, accurate, current, and maintained in compliance with applicable federal regulations, Good Clinical Practice (GCP), Institutional Review Board (IRB) requirements, sponsor requirements, company policies, and study-specific procedures.

The Regulatory Affairs Assistant works closely with Regulatory Affairs, Clinical Operations, Principal Investigators, study coordinators, sponsors, and other internal departments to support timely study start-up, ongoing regulatory maintenance, and study closeout activities.

Since its inception, QPS has been assisting pharmaceutical, biotechnology and medical device companies with their drug development efforts by providing a full range of services, including Early Phase Clinical and Phase II - IV Clinical Research services. The QPS location in Miami, Florida is a multi-specialty research center employing clinical research professionals, including board-certified physicians, in a 32,000 square foot space.

To meet the needs of our clients, we strive to employ talented, caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

Team members enjoy challenging and rewarding work, and are encouraged achieve their best. Underpinning the operation is a culture that values diversity, innovation, accountability, team work and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits, training, and advancement opportunities. Most importantly, we value each of our team members as employees and as individuals.

Please visit our website (  ) for more information and to see all current openings.

• Assist with the preparation, collection, review, and submission of regulatory documents to IRBs, sponsors, CROs, and other applicable parties.
• Support regulatory activities for study start-up, including initial submissions, amendments, renewals, continuing reviews, and study closures.
• Maintain accurate and complete regulatory binders and electronic regulatory files throughout the lifecycle of each clinical study.
• Assist with the preparation and maintenance of FDA Form 1572, investigator agreements, delegation logs, protocol signature pages, and related study documents.
• Track document expiration dates and follow up with appropriate staff to obtain updated licenses, certifications, training records, and other time-sensitive documents.
• Assist with the submission and distribution of protocol amendments, revised informed consent forms, safety reports, investigator brochures, and other regulatory communications.
• Verify that approved versions of protocols, informed consent forms, recruitment materials, and other study documents are properly filed and available to the study team.
• Maintain regulatory tracking logs, submission records, approval letters, correspondence, and document version histories.
• Communicate with study personnel regarding missing documents, regulatory deadlines, required signatures, and pending submissions.
• Initialize and maintain a continuing update of all required Institution, Investigator, and Site Staff credentials (e.g. updating CVs and gathering new licenses and GCP certificates).
• Support preparation for sponsor monitoring visits, internal audits, IRB reviews, and regulatory inspections.
• Assist with responding to regulatory document requests and resolving filing or documentation discrepancies.
• Upload and maintain study documents in applicable electronic systems, shared drives, databases, and clinical trial management systems.
• Protect confidential information and maintain compliance with HIPAA and company privacy and security requirements.

• Combination of relevant education & experience provides sufficient knowledge & skills to ensure incumbent's success in this role, such as:
• High school diploma or equivalent required. Associate or bachelor's degree in life…