Principal Investigator (Neurology)

Professional Case Management•Garden City, MI

44d•Remote

About The Position

Put your talents to work at PCM! Whether you work in our Home Care, Clinical Research, Impairments, or Catastrophic Care division, you will support our mission to deliver care and other services that enhance the quality of life of our clients. Be a part of our dynamic client-focused team and make a difference in your career! This is a 1099 Independent Contractor position. 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.

Requirements

A valid medical degree (MD or DO)
5+ years of clinical research experience as a PI or Sub-Investigator
Proficient with Microsoft Office Suite
An active medical license in good standing, with unrestricted ability to practice in place of work, where applicable
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

Responsibilities

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 educationally disadvantaged persons)
Promptly responding to all requests for information, including the timely submission of the research study for renewal
Ensuring that adequate resources and facilities are available to carry out the proposed research study
Ensure that each individual to whom a task is delegated, is qualified by virtue of education, training, and experience to perform
Ensuring that all associates, colleagues, and other personnel assisting in the conduct of the research study are appropriately informed of (i) the study procedures; (ii) informed consent requirements; (iii) the potential adverse events associated with study participation and the steps to be taken to reduce potential risks; (iv) reportable new information requirements; and (v) data collection and record-keeping criteria
Conducting the study in strict accordance with the approved research protocol except where a change may be necessary to eliminate an apparent immediate hazard to a given human research subject
Reporting of deviations that meet the definitions from the currently approved research protocol
Requesting approval of any proposed modification to the research protocol or informed consent documents prior to implementing such modifications
Obtaining prospectively and documenting informed consent in accordance with the current approved informed consent documents
Maintaining adequate, current, and accurate records of research data, outcomes, and reportable new information to permit an ongoing assessment of the risk/benefit ratio of study participation
Reporting promptly any internal or external adverse event that is considered to be unexpected, serious, and possibly or definitely related to the study
Reporting promptly any significant changes in the risk/benefit of study participation
Ensuring that, in the event a research subject experiences a significant adverse event, every reasonable effort is made to provide the subject with adequate care to correct or alleviate the consequences of the adverse event to the extent possible
Ensuring that human research subjects are kept fully informed of any new information that may affect their willingness to continue to participate in the research study
Ensuring that all listed investigators have the appropriate credentials to conduct the portion of the study in which they are involved and have completed the applicable company required training modules
Ensuring that conduct of the research study adheres to Good Clinical Practice guidelines
Maintaining adequate and accurate research subject records to reflect adherence to protocol specific requirements
Working in close collaboration with company quality and clinical operational oversight
Any other duties needed to help drive EmVenio’s purpose, fulfill our mission, and abide by our core values