Patricia Kaldas

Detail-oriented Clinical Research professional with 15+ years of progressive experience in regulatory compliance, clinical trial coordination, and quality assurance. Proven track record managing Phase II–IV trials from initiation through closeout across oncology, neurology, and CNS therapeutic areas. Adept at navigating FDA/ICH/GCP frameworks, building cross-functional relationships, and leading teams toward operational excellence.

Clinical Trials Research Specialist - Winship Cancer Institute of Emory University

(2021-11)

• Facilitate the protocol approval process and maintain regulatory compliance documentation for human subjects research throughout each trial's duration.
• Serve as primary site contact for assigned trials; correspond with institutional, federal, and pharmaceutical stakeholders.
• Complete new submissions, continuing reviews, amendment applications, and adverse event reports with the IRB and sponsoring entities.
• Review regulatory documentation to ensure alignment with IRB policies, FDA regulations, and applicable guidelines.
• Conduct source data verification and protocol compliance checks (eligibility criteria, informed consent).
• Provide direction and quality-standards feedback to research staff; manage identified compliance issues and escalate to leadership.
• Attend and report on regulatory matters at research team meetings; participate in in-service training.
• Support administrative functions related to budgets and contracts.

Regulatory Compliance Manager / Senior CRC - California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC)

(2007-01 - 2021-11)

• Served as the primary site regulatory contact for sponsored studies; led all site initiation and monitoring visits.
• Oversaw AE, SAE, and IND safety reporting; investigated deviations and managed CAPA processes for non-compliance findings.
• Prepared and submitted protocol amendments, consent form revisions, IND safety reports, and continuing reviews.
• Created, reviewed, and revised functional group SOPs; ensured staff awareness of FDA/ICH GCP standards.
• Maintained complete regulatory documentation for all study personnel (CVs, FDA 1572s, financial disclosures, delegation logs).
• Coordinated Phase II–IV clinical trials from enrollment through closeout; resolved data queries with sponsors and CROs.
• Recruited, screened, and enrolled study participants per protocol specifications.
• Conducted and participated in sponsor, CRO, and FDA audits; processed and shipped biological specimens per IATA standards.
• Administered cognitive assessments (MATRICS, UPSA) and trained staff on protocol updates and ICF changes.
• Developed and maintained eCRF platforms (Medidata Rave), source documents, and study databases.
• Mentored and trained new hires; collaborated on quality and process improvement initiatives.

Regulatory Compliance Coordinator - California Clinical Trials

(2005-11 - 2006-12)

• Managed regulatory compliance for Phase II–IV studies, including start-up submissions, amendments, and continuing IRB reviews.
• Prepared and processed all IRB documentation: initial submissions, biannual renewals, and adverse event reports.
• Maintained regulatory files for study personnel and resolved queries with IRBs, sponsors, and CROs.
• Reviewed response documents, study protocols, and informed consent forms for regulatory accuracy.

Bachelor of Arts - Psychology - University of California, Los Angeles (UCLA) (2005)