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Principal Investigator

Velocity Clinical Research
Santa Ana, CA
  • Posted: over a month ago
  • Full-Time
Job Description

 

Job Description

Job Title:

Principal Investigator 

Position Description:

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:

Site Manager/Director 

Position Qualification Requirements:

 

Education: 

  • Minimum qualifications include a Ph.D., M.D., or equivalent doctoral-level degree; an established record of independent research accomplishment; and current sponsored projects. 

 

Experience: 

  • 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).

 

Required Certifications: 

  • 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).

 

Required Skills: 

  • 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 

 

Position Responsibilities:

 

  • 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

 

 

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Velocity Head of Department

Velocity Clinical Research

Address

Santa Ana, CA
92704 USA

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