Clinical Research Physician

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Join to apply for the Clinical Research Physician role at Gen Harp Clinical Solutions

The Clinical Research Physician (Principal Investigator) role will be based in Evergreen Park, IL, and is a part-time contract position. This role is hybrid (remote and on-site). Job

Duties & Responsibilities:

The Clinical Physician Investigator will fulfill the role of Principal Investigator (PI) or Sub-Investigator (Sub-I) as the study dictates. This position is responsible for ensuring that the protocol is conducted to plan and in accordance with all applicable regulations. The Physician will conduct clinical projects and trials while overseeing subjects, clinical research staff, and data management.

Physician

Qualifications:

Possess experience in any of the following areas: pulmonary, neurology, family physician (care of elderly), maternal health, gastroenterology, and endocrinology. (

Note:

All areas of experience are encouraged to apply)
Maintain up-to-date curriculum vitae (CV), which reflects the requisite education, training, and certifications to act as a Principal Investigator (PI)
Maintain current licensure to practice as an MD in the State of Illinois Provide the sponsor, CRO, and institutional review board (IRB) with documentation of credentials as requested

Disclose conflicts of interest

Follow ICH-GCP, FDA CFR, and company SOPs and state guidelines

Work collaboratively with the entire research team Attend investigator meetings, site selection, site initiation meetings, and internal research meetings as assigned

Research Study Compliance:

Possess a thorough understanding of the requirements of each clinical trial protocol

Avoid protocol deviations or making any changes to protocol activities without agreement by the sponsor and prior review and approval by the IRB (except to eliminate an immediate hazard to the patient)
Healthcare Management of Clinical Research Subjects:

Possess familiarity with each clinical trial Investigator Brochure (IB)
Assess patient compliance with protocol activities, study drug(s), and or study device(s)
Evaluate and document adverse events, serious adverse events (AEs), and serious adverse events (SAEs) of special interest (SAESI)
Ensure provision of medical care and follow-up as needed for each AE/SAE/SAESIInform the subject’s primary care physician of their participation in a clinical trial and adverse events unless the subject declines consent for the investigator to communicate with the primary care physician.

Communicate in a timely manner with the medical monitor assigned by the sponsor to respond to and resolve any safety or eligibility concerns.

Human Subject Protection:

Report all serious adverse events and adverse events of special interest to the sponsor within 24 hours and to the IRB when the event meets the IRB’s reporting requirements

Obtain a signed and dated informed consent form from the patient or the patient’s legally authorized representative (LAR) prior to initiating any study-related procedures.

Assess and determine the subject’s understanding of the informed consent

Ensure subject assent if the subject is incapable of consent

Inform the patient and/or LAR about all aspects of the clinical trial

Provide new information about the study or study drug as it becomes available

Documentation:

Document protocol deviations

Cooperate with the site's CRA in the development of corrective and preventative action plans (CAPAs) as needed.

Document the informed consent process.

Document all adverse experiences with respect to AE term, causality, seriousness, and management

Comply with written procedures to document changes to data and/or case report forms.

Author formal progress notes at screening and randomization visits and at other critical junctures in the course of a subject’s trial participation

Investigational Product:

Possess familiarity with the use of the investigational product

Possess familiarity with the Investigator's Brochure, product insert, and other sources of information regarding the stud drug

Qualifications:

1+ years of clinical research…