Clinical Trials Quality and Regulatory

We’re Hiring: Quality & Regulatory Affairs Consultant (Part-Time)
Company: Total Outcomes Partners, LLCLocation: San Juan, Puerto Rico Metropolitan Area (Hybrid)Position Type: Part-Time Consultant (Professional Services)
About UsTotal Outcomes Partners, LLC provides specialized professional services to support the clinical trial operations of established clinical trial centers in oncology and other specialties. Our mission is to enhance the quality, efficiency, and compliance of clinical research through expert guidance and operational support. We are dedicated to upholding the highest standards of scientific integrity, patient safety, and regulatory excellence.
Position OverviewWe are seeking a highly qualified Quality & Regulatory Affairs Consultant (part-time) to provide expert oversight and strategic guidance for our clinical trials operations. The successful candidate will play a key role in ensuring that all trial protocols, site practices, and quality systems are fully compliant with local regulations, FDA requirements, and Good Clinical Practice (GCP) standards.
Key Responsibilities- Regulatory Oversight & Submissions: Lead the development and execution of regulatory strategies, including IRB/IEC submissions, protocol amendments, informed consent forms, and safety report filings.- Quality Assurance & Audits: Develop, update, and refine Standard Operating Procedures (SOPs); conduct internal quality audits; and ensure audit readiness for FDA and sponsor inspections.- Compliance Advisory: Provide expert interpretation and application of federal (FDA), local (Puerto Rico Health Department), and international (ICH-GCP) regulations relevant to oncology clinical trials.- CAPA Management: Oversee Corrective and Preventive Action (CAPA) investigations and implement solutions to address quality deviations or audit findings.- Site Training & Support: Advise clinical research coordinators and investigators on regulatory requirements and best practices for site documentation and source verification.
Qualifications & Requirements- Education: Bachelor’s degree in Life Sciences, Bioethics, Healthcare Administration, or a related field required.- Experience: Minimum of 5 years of progressive experience in regulatory affairs and quality management within clinical research (oncology experience highly preferred).- Regulatory Knowledge: Comprehensive knowledge of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312), ICH-GCP guidelines, and Puerto Rico healthcare regulations.- Certification: RACS (Regulatory Affairs Certification) or CQA (Certified Quality Auditor) strongly preferred.- Languages: Full professional proficiency in both Spanish and English (spoken and written) is required.- Location: Must reside in the San Juan Metropolitan Area or nearby municipalities to attend periodic on-site meetings, audits, and operational reviews.
How to ApplyIf you are a dedicated quality and regulatory professional with a passion for advancing oncology clinical trials in Puerto Rico, we encourage you to apply via LinkedIn or Indeed.