- Posted: over a month ago
The Principal Investigator responsibilities are centered around the execution, planning and management of assigned studies. Communicate succinctly with clients, study directors and technicians is key as is a cross-functional, flexible, and collaborative spirit. The Principal Investigator is responsible for the conduct of the clinical trial at a trial site.
Position Reports To:
Position Qualification Requirements:
- Minimum qualifications include a Ph.D., M.D., or equivalent doctoral-level degree; an established record of independent research accomplishment; and current sponsored projects.
- Oversee and be responsible for the conduct of clinical research that conforms with standards for Good Clinical Practice.
- Experience and training in the conduct of clinical research. Research experience (At least 1 year).
- Board certification (in specialty appropriate to the type of research being conducted at the site).
- Professional licensure (license must be valid in the state in which the research is conducted).
- Understanding of regulatory requirements, principles of GCP and biomedical research ethics.
Required Physical Abilites:
- Sit or stand for long periods of time
- Travel locally and nationally
- Communicate in person and by teleophone
- Limited Walking required
- Limited lifting up to 30 pounds
- Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice
- Provide medical and scientific feasibility of all 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
- Performs physical assessments and study procedures
- Reviews participants medical history
- Immediately report Serious Adverse Events (SAEs)—or any abnormalities affecting participants’ safety—to sponsors and to the REB as per specific reporting guidelines
- Administers Investigational Product
- Reviews and adheres to study protocol
- Participates in monitoring visits and sponsor meetings; Allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
- Maintains proper documentation
- Ensure that the study, consent, and other documents provided to the subject are approved by the REB and comply with GCP and other regulatory requirements
- Prior to starting the study, obtain ethical approval for protocol, informed consent form, recruitment materials, and other documents given to the patients
- Provide the REB with a copy of the Investigator’s brochure, product monograph, or information about the product or intervention to be studied so the REB can fully assess the risks involved
- During the study, inform the REB 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
- Ensure accuracy, completeness, legibility, and timeliness of data reported and be consistent with source documents
- Maintain trial documents specified by guidelines and as required by applicable regulatory requirements
- Retain 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
- Provide access to research-related records to monitors, auditors, representatives of the REB, 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 REB and, if the investigator terminates the trial without prior agreement, to the study sponsor
Velocity Head of Department
Velocity Clinical Research
AddressSanta Ana, CA
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