Professional Case Management
Principal Investigator (Pediatrics)
The Principal Investigator (PI) is responsible for conducting objective clinical research that generates independent, high quality and reproducible results. The PI manages the design, conduct, and reporting of research projects, ensuring compliance with federal regulations and sponsoring agency policies while overseeing financial, personnel, and collaborative aspects of the research.
Key Responsibilities
- • Minimize risks to research subjects by using procedures consistent with sound research design and that do not unnecessarily expose subjects to risk.
- • Ensure risks to human research subjects are reasonable in relation to anticipated benefits and importance of knowledge expected to result.
- • Ensure equitable selection of human subjects and patients for research participation.
- • Ensure individuals are adequately informed of risks and benefits and that informed consent is obtained in accordance with company policies and federal regulations.
- • Obtain and document informed consent of human research subjects in advance of participation.
- • Routinely monitor data collected to ensure safety of human research subjects where appropriate.
- • Protect privacy of human research subjects and maintain confidentiality of data.
- • Include appropriate additional safeguards to protect rights and welfare of vulnerable human research subjects.
- • Respond promptly to all requests for information including timely submission of research study for renewal.
- • Ensure adequate resources and facilities are available to carry out the proposed research study.
- • Ensure delegated tasks are performed by qualified individuals.
- • Inform all personnel assisting in the research study about study procedures, informed consent requirements, potential adverse events, reportable new information, and data collection and record-keeping criteria.
- • Conduct the study in strict accordance with the approved research protocol except to eliminate immediate hazards to subjects.
- • Report deviations from the approved research protocol.
- • Request approval for any proposed modifications to the research protocol or informed consent documents prior to implementation.
- • Obtain and document informed consent in accordance with approved documents.
- • Maintain adequate, current, and accurate records of research data, outcomes, and reportable new information.
- • Report promptly any unexpected, serious, and possibly or definitely related adverse events.
- • Report promptly any significant changes in the risk/benefit of study participation.
- • Provide adequate care to subjects experiencing significant adverse events to correct or alleviate consequences.
- • Keep human research subjects fully informed of any new information affecting their willingness to continue participation.
- • Ensure all listed investigators have appropriate credentials and have completed required training modules.
- • Ensure research conduct adheres to Good Clinical Practice guidelines.
- • Maintain adequate and accurate research subject records reflecting adherence to protocol requirements.
- • Work in close collaboration with company quality and clinical operational oversight.
- • Perform any other duties needed to help drive EmVenio’s purpose, fulfill mission, and abide by core values.
Required
- • 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.
Benefits & Perks
- • Medical
- • Dental
- • Vision
- • 401(k)
- • Company Paid Short Term Disability
- • Flexible Spending Account (FSA)
- • Health Savings Account (HSA)
- • Paid Time Off
- • Voluntary Benefits
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!
Qualifications
Individual base pay depends on various factors, in addition to primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience, skills and other market-based factors.
Available Benefits Include
Professional Case Management is an Equal Opportunity Employer.
- This is a 1099 Independent Contractor position.*
Qualifications
- 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.
- 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.
Individual base pay depends on various factors, in addition to primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience, skills and other market-based factors.
Available Benefits Include
- Medical
- Dental
- Vision
- 401(k)
- Company Paid Short Term Disability
- Flexible Spending Account (FSA)
- Health Savings Account (HSA)
- Paid Time Off
- Voluntary Benefits
Professional Case Management is an Equal Opportunity Employer.
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