Executive Director, Investigator Development / Sub-Investigator

🕒 2 dias atrás

🎸 Tennessee – Remoto

🎸 Tennessee – Remote

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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ObjectiveHealth

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🏥 Saúde

💼 Consultoria

⚕️ Seguro de Saúde

💰 $7.000.000 Venture Round em 2022-11

Healthcare • Consulting • Healthcare Insurance

ObjectiveHealth é uma empresa de saúde dedicada a integrar ensaios clínicos na prática médica padrão, particularmente no ponto de atendimento. Especializando-se em áreas como gastroenterologia, dermatologia, urologia, oncologia e distúrbios do metabolismo, a ObjectiveHealth oferece uma plataforma tecnológica única que facilita o recrutamento, triagem e gestão de ensaios clínicos. Através de parcerias com médicos e centros comunitários de saúde, a empresa melhora o acesso dos pacientes a ensaios clínicos avançados, fornecendo aos patrocinadores uma infraestrutura de pesquisa robusta. A ObjectiveHealth também busca melhorar os resultados dos pacientes por meio do uso inovador de registros eletrônicos de saúde e algoritmos de saúde para encontrar pacientes adequados para os ensaios e otimizar os resultados dos ensaios.

Descrição

• Partner with executive leadership to identify and develop future Investigators and research providers • Engage with new and emerging investigators to explain investigator responsibilities, expectations, and time commitments • Lead training and mentorship programs for new Principal Investigators and Sub-Investigators • Assess investigator readiness and provide individualized mentoring for clinical trial conduct • Facilitate mentoring on sponsor requirements and emerging industry best practices • Serve as a subject matter expert in clinical research regulations, investigator responsibilities, and GCP compliance • Advise investigators on protocol interpretation, study procedures, eligibility assessments, and participant management • Support investigators with CRIO • Participate in sponsor visits, Site Initiation Visits, monitoring visits, audits, and regulatory inspections as needed • Support and perform patient care activities, including informed consent, physical assessments, blood draws, specimen handling, medication administration, FibroScans, ECGs, and other protocol-required procedures • Investigate, track, and report Adverse Events and Serious Adverse Events as instructed by study sponsors • Monitor investigator effectiveness using performance metrics, quality indicators, audit findings, and compliance outcomes • Identify and implement updates to SOPs and policies affecting investigator roles and operational requirements • Attend investigator meetings and study-related training sessions required by sponsors • Review scientific literature and participate in continuing education, industry conferences, and seminars

🎯 Requisitos

• Must hold and maintain licensure as a Physician Assistant or Nurse Practitioner • Willingness to obtain and maintain multi-state licensure as appropriate • Prior experience in clinical research, preferably in a clinical role • At least two years of experience in industry-funded clinical research • Experience serving as a Sub-Investigator for Phase 2–3 clinical trials • Experience with EMR and/or EDC systems • Knowledge of biological and medical terminology • Ability to travel up to 40% • Legal authorization to work in the United States • Work visas are not currently accepted