About us
At Bioluminux, we pride ourselves on being professional, agile, and innovative. Our goal is to collaboratively develop new or improved treatments and interventions that advance patient care and health outcomes. We are committed to ensuring ethical standards, cultural sensitivity, and scientific rigor in all our research endeavors. Our work environment includes a modern office setting that fosters collaboration and creativity, allowing our team to excel in pioneering research that makes a tangible difference in the lives of patients. At Bioluminux, we strive to be at the forefront of medical advancements, driven by our dedication to improving health and well-being for all.
Overview
Bioluminux Clinical Research is a dedicated clinical trial Investigator site conducting innovative and quality late-phase clinical trial studies for the Pharmaceutical Industry and CROs. Due to recent expansion in Illinois, we are seeking to appoint a part-time experienced Principal Investigator (PI) to join our dedicated research team at our site in Milton Keynes. We are looking for Illinois board cerified Psychiatrists, Gastroenterologist, Immunologist and infectious Disease specialists.
The focus of this role is to act as Principal Investigator on studies in compliance with the protocol and ICH/GCP.
For this role, PI experience is essential with a Illinois State medical license.
Position Summary:
The Principal Investigator responsibility is to ensure that clinical trial studies run in accordance with national regulatory agency requirements and "Good Clinical Practice" (GCP). The PI will engage collaborative with the study team and Sponsors/CRA for the assigned clinical trial study.
Duties/Responsibilities:
- Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice
- Provide medical expertise and scientific feasibility for new sponsor inquiries
- Ensure that the safety and well-being of all participants in the study at the trial site are protected
- Ensure data collected at the study site is credible and accurate
- Ensure the rights, integrity, and confidentiality of all participants in the trial at the site are protected
- Assist and provide guidance to clinical operations, research staff, and to sponsor client managers as required
- Obtain and/or review participants’ medical history
- Perform physical assessments, examinations and study procedures as required by study protocols
- Evaluate and interpret clinical data and diagnostic information such as X-rays, ECGs and lab work.
- Immediately report Serious Adverse Events (SAEs)—or any abnormalities affecting participants’ safety—to sponsors and to the IRB as required by study specific reporting guidelines
- Oversee the administration of Investigational Product
- Review and adhere to study protocol
- Maintain proper documentation
- Ensure accuracy, completeness, legibility, and timeliness of data reported and be consistent with source documents
- Prior to starting a study and while a study is ongoing, ensure that the study, clinical trial protocol, informed consent form, recruitment materials, and other documents provided to the subject are approved by the IRB and comply with GCP (Good Clinical Practices) and other regulatory requirements as required.
- Ensure that the IRB is provided with a copy of the Investigator’s brochure, product monograph, or information about the product or intervention to be studied so the IRB can fully assess the risks involved
- During the study, ensure the IRB is informed of any changes to the protocol, Investigator’s brochure (or other safety information about the product/intervention), protocol deviations, or unanticipated problems
- Be thoroughly familiar with the appropriate use of the investigational product (study drug) as described in the protocol and Investigator’s brochure/product monograph and other documents provided by the sponsor
- Be aware and comply with ICH GCP (International Conference on Harmonization – Good Clinical Practice) and all applicable regulatory requirements
- Maintain trial documents as specified by guidelines and applicable regulatory requirements
- Ensure retention of essential documents until at least two years after the last approval of a marketing application or at least two years since formal discontinuation of the investigational product
- Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
- Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities
- Ensure participants are informed and receive appropriate therapy and follow-up if the trial is prematurely terminated or suspended for any reason
- Inform and provide a detailed written explanation of the termination/suspension of the trial to the IRB and, if the investigator terminates the trial without prior agreement, to the study sponsor
- Other duties as assigned
Qualifications
Required Skills/Abilities:
- Understanding of regulatory requirements, principles of GCP and biomedical research ethics.
- The ability to communicate effectively in a flexible and collaborative manner
- Critical thinking, dynamic problem-solving skills, and attention to detail
- Ability to occassionally attend study meetings, Investigator's meetings and other professional meeting as needed.
Education and Experience:
- Minimum qualifications include an M.D or D.O with an active Illinois State medical license.
- Training and certification in Good Clinical Practice (GCP)
- Board certification or board eligibility in a specialty appropriate to the type of research being conducted at the site.
The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change.
Job Types: Part-time, Contract
Pay: From $300.00 per hour
Expected hours: No less than 10 per week
Benefits:
- Opportunities for advancement
- Paid training
Schedule:
Travel requirement:
Application Question(s):
- Are you board certified in a medical speciality?
Experience:
- Principal Investigator's: 1 year (Required)
- Clinical trials: 1 year (Required)
License/Certification:
- Illinois Medical License (Required)
Work Location: Hybrid remote in Naperville, IL 60540