A Clinical Investigator works on a clinical trial, and is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The Clinical Investigator must also meet requirements set forth by the FDA, EMA or other regulatory body. The qualifications must be outlined in a current resume and readily available for auditors.
Research Site Director & Sub-Investigator Credential Requirement:
MD, DO, NP, or PA (Active, Unencumbered State License)
Location:
On-Site Position Type:
Full-Time / Leadership Role Overview We are seeking a highly motivated, dual-capable Research Site Director & Sub-Investigator to drive both operational excellence and clinical execution across our clinical research facility. This hybrid leadership role is designed for an ambitious clinician (MD, DO, NP, or PA) who wants to blend direct patient care in clinical trials with macro-level site management. Working in direct partnership with our Principal Investigator (PI) and executive team, you will oversee day-to-day site operations, lead clinical research staff, maintain strict GCP/regulatory compliance, and conduct study-related protocol visits as a Sub-Investigator. If you thrive in a fast-paced environment, love clinical research, and are ready to take full operational ownership of a growing site, this role offers an exceptional platform for professional advancement. Key Responsibilities 1. Clinical Research & Sub-Investigator Duties Serve as Sub-Investigator on active pharmaceutical and medical device clinical trials in compliance with FDA regulations, ICH GCP guidelines, and protocol specifications. Conduct protocol-required physical exams, medical history reviews, laboratory assessments, and diagnostic interpretations (e.g., EKGs, vitals). Evaluate subject eligibility by assessing complex inclusion/exclusion criteria during screening visits. Perform ongoing safety assessments, monitor adverse events (AEs/SAEs), and assist the PI in evaluating causality and reporting timelines. Administer or supervise investigational product (IP) dosing and maintain oversight of patient safety throughout the trial lifecycle. Participate in pre-study site visits (PSVs), site initiation visits (SIVs), monitor visits, and sponsor audits. 2. Site Operations & Team Leadership Direct and supervise day-to-day site operations, ensuring clinical staff (Clinical Research Coordinators, Regulatory Specialists, Lab Techs, and Assistants) execute duties efficiently and compliantly. Manage site workflow, participant scheduling, and resource allocation to meet or exceed enrollment and retention targets. Oversee quality control across site operations, ensuring source documentation, eCRF completion, and regulatory files remain continuously audit-ready. Build a positive, accountable team culture focused on patient safety, high-quality data collection, and operational efficiency. Drive site readiness for new study launches, ensuring seamless onboarding and protocol training for all clinical personnel.
Qualifications & Requirements Licensure:
Active, unencumbered state medical license as a Doctor of Medicine (MD), Doctor of Osteopathic Medicine (DO), Nurse Practitioner (NP), or Physician Assistant (PA).
Certifications:
Active DEA registration (or eligibility) and current
BLS/ACLS
certification.
Clinical Research Experience:
Prior experience in clinical trials (as a Sub-Investigator, CRC, or Site Leader) is strongly preferred, with demonstrated knowledge of ICH E6 (R3) GCP guidelines, FDA regulations, and IRB processes.
Leadership Capability:
Proven ability to manage, train, and mentor clinical staff, resolve operational bottlenecks, and maintain high team performance.
Technical Proficiency:
Experience navigating Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), and eSource platforms.
Attributes:
High internal drive, excellent interpersonal and communication skills, meticulous attention to detail, and a proactive approach to site growth.
What We Offer Executive Impact:
Direct leadership over site operations with the opportunity to shape culture and workflow.
Competitive Compensation:
Salary commensurate with credentials and experience, plus performance-aligned incentives tied to site milestones.
Career Advancement:
Continuous exposure to cutting-edge clinical trials, sponsor relationships, and advanced site administration.
