Part time: 6 - 10 hours/week

Must be MD or DO Licensed in United States, for a Gastroenterologist to fill a PI or Sub-I role for a sponsor study. The candidate must have PI or Sub-I experience and can be based anywhere in the US as this is a remote position for a decentralized clinical trial. Start date is ASAP.

The Investigator supporting the RWE Clinical Trials business will be responsible for ensuring conduct of the study is compliant with federal and industry guidance & regulations.

Job Description:

K3-Innovations is seeking a highly skilled and motivated Investigator with active, unrestricted medical license in the United States, preferably near one of the following states: MA, KS, MO, NJ, NV, TX, FL

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

· Board certification in gastroenterology

· Knowledge of clinical trials, and experience applying applicable clinical research regulatory requirements (i.e.. GCP and ICH guidelines)

· Principal or Sub-Investigator experience is a must

· Research experience is a must