Job Description

Overview

The Principal Investigator (PI) is responsible for conducting objective clinical research that generates independent, high quality and reproducible results. The PI is charged with the management and integrity of the design, conduct and reporting of the research project and for managing, monitoring and ensuring the integrity of any collaborative or delegated relationships. Additionally, the PI is responsible for the direction and oversight of compliance, financial, personnel and other related aspects of the research project and for coordination with necessary departments to assure the research is conducted in accordance with federal regulations and sponsoring agency policy and procedures. The PI is agreeing to assume the overall responsibility for the study conduct.

General Responsibilities

• Responsibilities can be delegated in mutual agreement between the PI and company.
• Risks to research subjects are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose the subjects to risk; and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes;
• Risks to human research subjects are reasonable in relation to the anticipated benefits (if any) to the individual, and the importance of the knowledge that may be expected to result;
• Selection of human subjects and patients for research participation is equitable;
• Individuals are adequately informed of the risks and benefits of research participation and the procedures that will be involved in the research, and that informed consent will be obtained from each prospective human research subject, or his/her legally authorized representative, in accordance with, and to the extent required, by company policies and federal regulations;
• Informed consent of human research subjects will be obtained in advance of research participation and appropriately documented in accordance with, and to the extent required, by company policies and federal regulations;
• Where appropriate, there is routine monitoring of the data collected to ensure the safety of human research subjects;
• The privacy of human research subjects is protected and the confidentiality of data is maintained;
• Appropriate additional safeguards are included in the study to protect the rights and welfare of human research subjects who are likely to be vulnerable to coercion or undue influence (e.g., children, prisoners, individuals with impaired decision-making capacity, or economically or

Education:

• MD/DO with active license
• Board certified
• Clinical research experience as a PI or Sub-Investigator preferred

Knowledge, Skills and Abilities:

• Demonstrated leadership skills, including strong communication, presentation, written and interpersonal skills.
• Proven ability to be highly collaborative and quickly establish credibility and gain participation across a variety of stakeholders, both internal and external.
• Results-driven, with a track record of building, managing and motivating teams to meet or exceed clinical goals and objectives.
• Strong analytical and decision-making capabilities that support clinical continuous improvement initiatives.
• Advanced organizational and project management abilities, including the ability to work within tight deadlines on a range of projects.
• Must be a self-starter and highly-motivated individual who can identify needs and proactively work to solve problems and gaps

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