Job Description for Physician Investigator

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Overview

Lightship is the premier provider of enterprise level, direct-to-patient clinical research solutions. We are a high performing, technologically enabled organization that operates as a Direct-to-Patient clinical research site, engaging patients at home and making participation in research accessible to everyone. We utilize direct patient outreach, mobile clinical research nursing, and telemedicine capabilities to accomplish our studies in an effective and regulatory compliant manner. Patients remain connected to their primary healthcare providers and take part in Lightship studies as an additional treatment option.

We are seeking an experienced physician to join our team as a physician investigator on a consultant basis to become a member of Lightship’s network of investigators, with all the associated support from our centralized research personnel. This includes mobile research nurses, clinical study managers, and other support personnel who organize study activities directly with the patients on your behalf. You will spend more time meaningfully interacting with the research patients and less time on preparation and organization of study visits, which will be arranged for you by Lightship study personnel.

The ideal candidate will be an MD or DO, licensed in at least one state for three or more years, who has experience in clinical research as a Principal Investigator on at least five sponsored clinical trials.

This consultant position is remote, and a successful candidate will possess a willingness and desire to work independently without significant supervision.

You will be responsible for:

• Completing and following all Lightship-specific agreements, including invoicing procedures
• Completing telemedicine training and other training activities provided by Lightship, including those related GCP, Biomedical Research, and Lightship-specific SOPs
• Working with the Lightship study teams to plan and execute clinical research studies, which will be assigned to you based on your education, training, and experience
• Adhering to relevant federal, state, and local research regulations (e.g. 21 CFR 321, 21 CFR 812, ICH GCP, state licensing laws, etc.)
• Following study protocols and executing investigator responsibilities per applicable regulations and Lightship’s SOPs
• Delegating study activities to the appropriately trained and qualified study personnel, while retaining study oversight; providing oversight of study activities, including study personnel and study patients
• Ensuring that the rights, safety, and wellbeing of study patients are protected
• Providing reasonable medical care to study patients for issues related to study participation and facilitating care of health issues that may arise during the study
• Ensuring that informed consent is properly obtained; study product is properly dispensed and delivered to the patients; and all adverse events are reported per protocol
• Working with the Lightship team to complete proper reporting to the study sponsor and to maintain all study documentation
• Reporting financial interests or conflicts of interest as required by the study sponsor
• Participating in Lightship’s FDA inspection readiness training; participating in audits and inspections as required for the study

We are excited to speak with someone who has:

• Required knowledge, skills, and abilities
• Extensive knowledge of human subjects’ research and applicable regulations
• Ability to follow a clinical protocol and comply with study specific procedures
• Ability to properly delegate research responsibilities to qualified personnel
• Knowledge of basic documentation practices and requirements in clinical research
• Adequate technological skills to adapt to new programs, systems, and devices
• Ability and comfort in remotely supervising personnel
• Strong verbal and written communication skills
• Education and experience
• MD or DO, preferred
• Licensed in at least one state for 3 or more years
• Experience as a Principal Investigator on at least 5 sponsored clinical trials during the past 3 years in the area of practice
• Has not been debarred by the FDA
• Has not been denied hospital or clinical privileges
• Has not been disqualified from participation in any clinical investigation or engaged in any acts that could be considered for such disqualification
• Does not have a conviction for an offense related to healthcare
• Is not listed by a federal agency as debarred, excluded, disqualified, or otherwise ineligible for participation in a federal program
• License to practice medicine is any jurisdiction is not currently suspended, revoked, on probation, or otherwise restricted