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.