Regulatory Affairs Assistant

QPS Holdings, LLC; Miami (FL); Sur place; USD 50 000 - 65 000; Plein temps

Avantages offerts par ce poste

Learning and development opportunities

Bonuses and merit increases

Wide range of benefits including 401(k

Résumé du poste

QPS Holdings, LLC in Miami, FL is seeking a Regulatory Affairs Assistant responsible for preparing, organizing, submitting, and maintaining regulatory documents for clinical studies. You will ensure records are complete, accurate and compliant with GCP, IRB, sponsor, and company requirements, coordinating with multiple internal teams.

The role supports start-up, ongoing maintenance, and closeout activities, maintaining binders and electronic files, and assisting with FDA forms, amendments, and

Qualifications

• Combination of relevant education & experience provides success in this role.
• High school diploma or equivalent required; Associate/Bachelor's preferred in life sciences, healthcare administration, regulatory affairs, business administration.

Responsabilités

• Assist with preparation, collection, review, and submission of regulatory documents to IRBs, sponsors, CROs, and other parties.
• Support regulatory activities for study start-up, including submissions, amendments, renewals, continuing reviews, and study closures.
• Maintain regulatory binders and electronic regulatory files across each clinical study lifecycle.
• Assist with FDA Form 1572, investigator agreements, delegation logs, protocol signatures, and related documents.
• Track document expiration dates and obtain updated licenses, certifications, and training records.
• Submit and distribute protocol amendments, revised consent forms, safety reports, and regulatory communications.
• File and provide access to approved protocol documents for study team.
• Maintain regulatory tracking logs, letters, correspondence, and version histories.
• Communicate missing documents, deadlines, signatures, and pending submissions with study personnel.
• Update credentials (CVs, licenses, GCP certificates) for Institutions, Investigators, Site Staff.
• Assist sponsor monitoring visits, internal audits, IRB reviews, and regulatory inspections.
• Respond to regulatory document requests and resolve filing discrepancies.
• Upload and maintain study documents in electronic systems and shared drives.
• Protect confidential information and ensure HIPAA compliance.

Connaissances

Regulatory knowledge

Documentation management

Attention to detail

Communication

Team collaboration

Formation

High school diploma or equivalent

Associate or Bachelor's in life sciences/healthcare/regulatory affairs/business administration

Outils

Regulatory databases

Electronic Trial Management Systems (eTMF/CTMS)

Description du poste

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Regulatory Affairs Assistant

Full Time Regular Admin Support Miami, FL, US

6 days ago Requisition ID: 3264

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 ( www.qps.com ) for more information and to see all current openings.

The Job

• 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.

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 sciences, healthcare administration, regulatory affairs, business administration, or a related field preferred.

Why You Should Apply

• Great learning opportunities, especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
• Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual, team and company performance.
• Solid Benefits package, including Company-matched 401(k), and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance

QPS is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.