Sub Investigator

Sub Investigator Overview

• The Sub Investigator supports clinical research by performing delegated medical and study-related responsibilities in accordance with protocols and regulatory standards.
• Ensure participant safety and data integrity while adhering to Good Clinical Practice (GCP) guidelines and ethical standards.
• Collaborate with Principal Investigator and research team to evaluate participant eligibility and compliance with study protocols.
• Conduct medical assessments, including physical examinations and clinical evaluations, as required by study protocols.
• Review and interpret laboratory results, diagnostic reports, and safety data to ensure participant welfare.
• Support informed consent processes and address participant questions regarding study participation.
• Participate in sponsor meetings, audits, and inspections to ensure compliance and protocol adherence.
• Maintain participant confidentiality and comply with HIPAA and FDA regulations.
• Flexibility in schedule to accommodate study enrollment and participant needs.

Sub Investigator Key Responsibilities & Duties

• Complete required sponsor, protocol, and GCP training within specified timelines.
• Assess participant eligibility by reviewing medical history, laboratory results, and clinical information.
• Conduct protocol-required medical assessments and clinical evaluations within scope of practice.
• Evaluate participants for adverse events and ensure appropriate medical care is provided.
• Collaborate with research coordinators and sponsors regarding participant safety and protocol compliance.
• Complete and sign study documentation accurately and within required timelines.
• Identify and communicate protocol deviations or safety concerns to the research team.
• Participate in study-related meetings, audits, and inspections as required.
• Maintain proficiency with clinical trial systems and electronic medical records.

Sub Investigator Job Requirements

• Current, unrestricted professional license as a physician, nurse practitioner, or physician assistant.
• Graduate of an accredited professional program; board certification preferred.
• Minimum of 1 year clinical experience; oncology and clinical research experience preferred.
• Knowledge of GCP, FDA regulations, and clinical research documentation requirements.
• Strong clinical judgment and ability to respond to participant condition changes.
• Proficiency with electronic medical records and Microsoft Office applications.
• Excellent organizational skills and attention to detail for documentation accuracy.
• Ability to maintain schedule flexibility based on study and participant needs.
• Willingness to travel for investigator meetings and study-related activities.