K3-Innovations, Inc. · 9 hours ago
Principal Investigator - Texas, Licensed with Vaccine (RSV) research experience - part-time
KC Metro Area
Part-time
Hybrid
Senior Level, Lead/Staff
1+ years expK3-Innovations, Inc. is seeking a Principal Investigator with vaccine research experience to support their RWE Clinical Trials business. The role involves ensuring compliance with federal and industry regulations during clinical studies, as well as overseeing the research team and participant safety.
Health CareMedicalMedical DevicePharmaceutical
Hiring Manager
Ilene Brooks
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
Qualification
Required
Must be Licensed in Texas
Must have vaccine research experience
Must have Principal Investigator experience
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
Preferred
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
Company
K3-Innovations, Inc.
K3-Innovations is redefining clinical research with a strategic scaling approach, blending AI-powered automation, adaptive clinical resourcing, and advanced data science.
51-200 employees
H1B Sponsorship
K3-Innovations, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2023 (2)
2022 (3)
2021 (3)
2020 (2)
Funding
Current Stage
Growth StageCompany data provided by crunchbase