M.D. or D.O. with an active medical license valid in the state of research.
Training and certification in Good Clinical Practice (GCP).
Board certification or eligibility in a relevant specialty for research.
Effective verbal and written communication skills in collaborative settings.
Strong critical thinking and problem-solving skills.
Responsibilities
Provide medical direction and review protocols in line with investigational plans and GCP.
Evaluate scientific feasibility of new sponsor inquiries.
Protect the safety and well-being of study participants at the trial site.
Ensure data integrity and credibility collected at the site.
Guide clinical operations and research staff as needed.
Complete and review participant medical histories accurately.
Conduct physical assessments and necessary study procedures according to protocols.
Benefits
Opportunity to lead clinical trials with significant impact.
Work in a collaborative environment with cross-functional teams.
Engage in continuous learning and professional development opportunities.
Limited travel requirements (up to 10%) for meetings and conferences.
Full Job Description
Position Summary:
The Principal Investigator responsibilities are centered around the execution, planning and management of assigned studies. Communicate succinctly with clients, study directors and technicians are 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
Responsibilities
Duties/Responsibilities:
Provide overall medical direction and medical review of protocols in conformance with the investigational plan and good clinical practice
Provide medical expertise and scientific feasibility for 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
Obtain and/or review participants' medical history
Perform physical assessments, examinations and study procedures as required by study protocols
Evaluate and interpret clinical data and diagnostic information such as X-rays, ECGs and lab work.
Immediately report Serious Adverse Events (SAEs)-or any abnormalities affecting participants' safety-to sponsors and to the IRB as required by study specific reporting guidelines
Oversee the administration of Investigational Product
Review and adhere to study protocol
Maintain proper documentation
Ensure accuracy, completeness, legibility, and timeliness of data reported and be consistent with source documents
Prior to starting a study and while a study is ongoing, ensure that the study, clinical trial protocol, informed consent form, recruitment materials, and other documents provided to the subject are approved by the IRB and comply with GCP (Good Clinical Practices) and other regulatory requirements as required.
Ensure that the IRB is provided with a copy of the Investigator's brochure, product monograph, or information about the product or intervention to be studied so the IRB can fully assess the risks involved
During the study, ensure the IRB is informed 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
Maintain trial documents as specified by guidelines and applicable regulatory requirements
Ensure retention of 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
Participate in monitoring visits and sponsor meetings; allow monitoring and auditing by sponsors and inspection by appropriate regulatory agencies
Provide access to research-related records to monitors, auditors, representatives of the IRB, 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 IRB and, if the investigator terminates the trial without prior agreement, to the study sponsor
Other duties as assigned
Qualifications
Required Skills/Abilities:
Understanding of regulatory requirements, principles of GCP and biomedical research ethics.
The ability to communicate effectively in a flexible and collaborative manner
Critical thinking, dynamic problem-solving skills, and attention to detail
Ability to travel for work related purposes (Up to 10% travel, as needed, for project team meetings, client presentations and other professional meetings/conferences as needed.)
Education and Experience:
Minimum qualifications include an M.D or D.O with an active medical license (medical license must be valid in the state in which the research is conducted).
Training and certification in Good Clinical Practice (GCP)
Board certification or board eligibility in a specialty appropriate to the type of research being conducted at the site.
Medical licensure (license must be valid in the state in which the research is conducted).
Training and certification in Velocity required trainings and Standard Operating Procedures (SOP's).
NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management.
