Principal Investigator

Company Description

SDS Clinical Trials partners with sponsors and CROs to deliver rapid study enrollment, high subject retention, meticulous data, and on-time study completion. By leveraging a central IRB and a robust database of more than 100,000 patients, the organization’s experienced bilingual staff efficiently meets and often exceeds study goals. SDS Clinical Trials is strongly committed to patient safety, quality, and operational efficiency in every phase of clinical research. With over 20 years of experience, its Board-Certified Principal and Sub-Investigators cover a wide range of therapeutic areas and provide dignified, compassionate care to study participants. The team strictly adheres to FDA regulations, ICH/GCP guidelines, IRB standards, HIPAA, and sponsor requirements while maintaining high ethical standards.

Role Description

The Principal Investigator is a full-time, on-site role based in Orange, CA, responsible for the overall conduct of assigned clinical trials. This role oversees study design implementation, protocol compliance, and the protection of participant rights, safety, and welfare. Day-to-day responsibilities include reviewing and approving study protocols and informed consent documents, performing eligibility assessments, conducting study visits, and documenting clinical findings accurately in source documents and case report forms. The Principal Investigator will supervise and mentor the research team, collaborate with sponsors and CROs, attend investigator meetings, and respond to monitoring and audit queries. This position also requires maintaining up-to-date knowledge of relevant therapeutic areas and regulatory changes, and ensuring timely reporting of safety events and study data according to all applicable guidelines.

Qualifications

• Clinical and medical expertise in relevant therapeutic areas, with Board Certification and an active, unrestricted medical license (e.g., MD or DO).
• Demonstrated experience leading or serving as an investigator in clinical trials, with strong skills in patient assessment, informed consent, and protocol adherence.
• Thorough understanding of FDA regulations, ICH/GCP guidelines, IRB processes, HIPAA requirements, and sponsor protocols, with a proven record of regulatory compliance.
• Ability to manage study operations, including team oversight, subject recruitment and retention, data review, and timely reporting to sponsors and regulatory bodies.
• Strong analytical and documentation skills, including accurate medical charting, source documentation, and review of case report forms and query resolutions.
• Excellent interpersonal and communication skills to work effectively with patients, research staff, sponsors, CROs, and regulatory representatives; bilingual ability is a plus.
• High ethical standards, sound clinical judgment, and a consistent focus on patient safety, quality of care, and integrity of study data.
• Prior experience in an outpatient clinical research site or similar environment; familiarity with electronic data capture (EDC)