** Must be Licensed in Texas **

** Must have vaccine research experience **

** Must have Principal Investigator experience **

Job Summary

The Principal Investigator supporting the RWE Clinical Trials business will be responsible for ensuring conduct of the study is compliant with federal and industry guidance & regulations. Hours range from up to 10 hours per week during 2 months of enrollment then ~5 hours per week for the rest of the study. Duration TBD for this study, approximate start April 2026.

Job Responsibilities

• Report adverse events in a timely manner; review sponsor provided safety reports.
• Provide training to sub-investigators and study team members on study protocol.
• Sign off on electronic case books as required per study guidelines.
• Review informed consent forms.
• Review the inclusion/exclusion criteria, endpoint criteria, and investigational article use with the internal research team.
• Determine whether inclusion/exclusion criteria apply to the study population.
• Maintain protocol compliance on all clinical trials/studies according to the International Conference on Harmonization-Good Clinical -Practice (ICH-GCP), local regulations, and study protocol.
• Oversee IRB review of study and ensure written IRB approval is obtained before initiating the study or instituting any changes to the protocol as approved.
• Assess subject response to therapy, evaluate and address adverse experiences
• Meet regularly with the research team to discuss subject participation and protocol progress.
• Meet with study assigned monitors at regular intervals
• Train Sub-Investigators and study staff members on protocol and protocol specific procedures.
• Provide medical support to Sub-Investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
• Maintain essential documents and records necessary for conduction of study.
• Train on and implement Standard Operating Procedures.
• Review sponsor provided safety reports.
• Review and maintain accurate case report forms.
• Sign off electronic case books as required by the study sponsor.
• Provide clinical oversight and quality of the studies virtually.
• Ensure the medical well-being and safety of the study participants, through the safe performance and execution of the clinical trials/studies.
• Participate and engage in driving delivery of study targets, such as: participant recruitment, enrollment, and retention.
• Perform other duties as assigned.

Basic Qualifications & Interests (BQIs)

• MD/DO license in good standing
• Knowledge of clinical trials, and experience applying applicable clinical research regulatory requirements (i.e. GCP and ICH guidelines)
• Principal Investigator experience
• Vaccine Research experience is a must

Travel Requirements

Percentage

Primarily remote role, PI might be required on site for some monitoring visits and symptomatic visits (this can be delegated to Sub-I as applicable)

Preferred Qualifications & Interests (PQIs)

• At least 1 year of PI experience
• At least 1 year of clinical research experience
• Knowledge of EDC systems and technology enabled solutions (EMR/Health Record Experience, Hybrid trials) with respect to use in clinical trials.