Prinicipal Investigator

Summary

DescriptionPosition SummaryThe Principal Investigator (PI) provides medical leadership and regulatory oversight for industry-sponsored clinical trials conducted at the site. The PI retains ultimate responsibility for the conduct of assigned studies in accordance with FDA regulations and ICH‑GCP guidelines, while working within a highly supported research model that includes full‑time, experienced mid‑level Sub‑Investigators (NPs/PAs) and dedicated clinical research staff.This role is well‑suited for both experienced PIs and clinicians new to the PI role, offering robust operational support that allows the PI to focus on medical decision‑making, subject safety, regulatory compliance, and Sponsor collaboration.Key ResponsibilitiesClinical & Regulatory OversightServe as Principal Investigator for industry-sponsored clinical trials within assigned therapeutic areasMaintain ultimate regulatory responsibility for study conduct, subject safety, and protocol complianceAppropriately delegate study‑related activities to qualified Sub‑Investigators and research staff while providing ongoing supervision in accordance with FDA regulations and ICH‑GCPProvide medical oversight for subject eligibility, treatment decisions, and clinical assessmentsReview, assess, and approve adverse events (AEs), serious adverse events (SAEs), safety narratives, and protocol deviationsEnsure informed consent processes are conducted appropriately and consistentlyParticipate in monitoring visits, audits, and regulatory inspections as requiredCollaborative Research ModelSupervise and collaborate with full‑time mid‑level Sub‑Investigators (NPs/PAs) who support protocol‑required visits and assessments under the PI's oversightWork closely with Study Coordinators and site leadership to ensure high‑quality study executionContribute to a culture of quality, compliance, and patient‑centered researchPatient Engagement & Community CollaborationSupport patient engagement and retention initiatives designed to improve awareness of clinical research opportunitiesCollaborate with local healthcare providers, referral partners, and community organizations to provide education and information about ongoing and upcoming research studiesServe as a clinical resource to help expand access to research for the local patient populationSponsor Engagement & Business DevelopmentServe as a medical and scientific representative of the site in interactions with Sponsors and CROsParticipate in feasibility assessments, protocol review, and protocol design consultation when requestedSupport business development efforts through key client meetings, bid defenses, and therapeutic area discussionsContribute clinical insight to support study selection and research program growthRequirementsSpecialty FocusPsychiatryMood disorders, anxiety disorders, depression, schizophrenia, and related psychiatric indicationsCNSAlzheimer's disease, Parkinson's disease, neurodegenerative, cognitive, and neurological disordersGastroenterologyNASH/MASH, IBS‑C, IBS‑D, metabolic liver disease, and functional GI disordersQualificationsMD or DO (required)Board‑certified or board‑eligible in relevant specialtyActive, unrestricted medical licenseInterest in or prior experience with industry‑sponsored clinical researchStrong understanding of, or willingness to be trained in, FDA regulations and ICH‑GCPExcellent communication, documentation, and collaborative leadership skills#J-18808-Ljbffr

Job Description

DescriptionPosition SummaryThe Principal Investigator (PI) provides medical leadership and regulatory oversight for industry-sponsored clinical trials conducted at the site. The PI retains ultimate responsibility for the conduct of assigned studies in accordance with FDA regulations and ICH‑GCP guidelines, while working within a highly supported research model that includes full‑time, experienced mid‑level Sub‑Investigators (NPs/PAs) and dedicated clinical research staff.This role is well‑suited for both experienced PIs and clinicians new to the PI role, offering robust operational support that allows the PI to focus on medical decision‑making, subject safety, regulatory compliance, and Sponsor collaboration.Key ResponsibilitiesClinical & Regulatory OversightServe as Principal Investigator for industry-sponsored clinical trials within assigned therapeutic areasMaintain ultimate regulatory responsibility for study conduct, subject safety, and protocol complianceAppropriately delegate study‑related activities to qualified Sub‑Investigators and research staff while providing ongoing supervision in accordance with FDA regulations and ICH‑GCPProvide medical oversight for subject eligibility, treatment decisions, and clinical assessmentsReview, assess, and approve adverse events (AEs), serious adverse events (SAEs), safety narratives, and protocol deviationsEnsure informed consent processes are conducted appropriately and consistentlyParticipate in monitoring visits, audits, and regulatory inspections as requiredCollaborative Research ModelSupervise and collaborate with full‑time mid‑level Sub‑Investigators (NPs/PAs) who support protocol‑required visits and assessments under the PI's oversightWork closely with Study Coordinators and site leadership to ensure high‑quality study executionContribute to a culture of quality, compliance, and patient‑centered researchPatient Engagement & Community CollaborationSupport patient engagement and retention initiatives designed to improve awareness of clinical research opportunitiesCollaborate with local healthcare providers, referral partners, and community organizations to provide education and information about ongoing and upcoming research studiesServe as a clinical resource to help expand access to research for the local patient populationSponsor Engagement & Business DevelopmentServe as a medical and scientific representative of the site in interactions with Sponsors and CROsParticipate in feasibility assessments, protocol review, and protocol design consultation when requestedSupport business development efforts through key client meetings, bid defenses, and therapeutic area discussionsContribute clinical insight to support study selection and research program growthRequirementsSpecialty FocusPsychiatryMood disorders, anxiety disorders, depression, schizophrenia, and related psychiatric indicationsCNSAlzheimer's disease, Parkinson's disease, neurodegenerative, cognitive, and neurological disordersGastroenterologyNASH/MASH, IBS‑C, IBS‑D, metabolic liver disease, and functional GI disordersQualificationsMD or DO (required)Board‑certified or board‑eligible in relevant specialtyActive, unrestricted medical licenseInterest in or prior experience with industry‑sponsored clinical researchStrong understanding of, or willingness to be trained in, FDA regulations and ICH‑GCPExcellent communication, documentation, and collaborative leadership skills#J-18808-Ljbffr