Executive Director, Investigator Development / Sub-Investigator

This is a fully remote position, open to applicants in Tennessee.

📋 Description

• Collaborate with executive leadership to pinpoint and cultivate future Investigators and research providers.

• Engage with new and emerging investigators to clarify investigator responsibilities, expectations, and time commitments.

• Oversee training and mentorship programs for new Principal Investigators and Sub-Investigators.

• Evaluate investigator preparedness and offer tailored mentoring for clinical trial execution.

• Facilitate guidance on sponsor requirements and the latest industry best practices.

• Act as a subject matter expert in clinical research regulations, investigator duties, and GCP compliance.

• Provide counsel to investigators on protocol interpretation, study procedures, eligibility evaluations, and participant management.

• Assist investigators with CRIO.

• Participate in sponsor visits, Site Initiation Visits, monitoring visits, audits, and regulatory inspections as required.

• Support and execute patient care activities, encompassing informed consent, physical assessments, blood draws, specimen handling, medication administration, FibroScans, ECGs, and other protocol-required procedures.

• Investigate, monitor, and report Adverse Events and Serious Adverse Events as directed by study sponsors.

• Assess investigator performance utilizing performance metrics, quality indicators, audit findings, and compliance outcomes.

• Identify and implement revisions to SOPs and policies impacting investigator roles and operational requirements.

• Attend investigator meetings and study-related training sessions mandated by sponsors.

• Review scientific literature and engage in continuing education, industry conferences, and seminars.

⛳️ Requirements

• Must possess and maintain licensure as a Physician Assistant or Nurse Practitioner.

• Willingness to acquire and sustain multi-state licensure as necessary.

• Previous experience in clinical research, ideally in a clinical capacity.

• Minimum of two years of experience in industry-funded clinical research.

• Experience as a Sub-Investigator for Phase 2–3 clinical trials.

• Familiarity with EMR and/or EDC systems.

• Knowledge of biological and medical terminology.

• Ability to travel up to 40% of the time.

• Legal authorization to work in the United States.

• Work visas are not currently accepted.

🏝️ Benefits

• Comprehensive health, dental, and vision insurance.

• Retirement plan options with employer matching.

• Opportunities for professional development and continuing education.

• Generous paid time off and holiday schedule.

• Supportive and collaborative work environment.