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    Staff Investigator I - Dallas, TX, United States - EmVenio Research

    EmVenio Research
    EmVenio Research Dallas, TX, United States

    3 weeks ago

    Default job background
    Full time
    Description

    ABOUT EMVENIO RESEARCH:
    EmVenio Research delivers localized trial access to diverse and underserved communities. We empower patients and embrace communities on their terms. Our research solutions cultivate a sustainable local ecosystem that benefits all stakeholders. Removing barriers and unlocking doors to innovation reduces risk and time associated with clinical research, while improving ROI.

    We promote a diverse and inclusive workplace, and our team members have a voice in their work through surveys and town halls.

    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.

    The PI is responsible for the direction and oversight of compliance, financial, personnel and other related aspects of the research project.

    Additionally, the PI is responsible for coordination with necessary departments to assure the research is conducted in accordance with federal regulations and sponsoring agency policy and procedures.

    Leads the study team to execute clinical trials by mentoring and training staff in the conduct of clinical trials, protocol requirements, communication, and trial management skills.

    ~ Ensures privacy of human research subjects is protected, and the confidentiality of data is maintained.
    ~ Implements and coordinates contracted clinical trials including start up, vendor management, subject recruitment, source development review, protocol training, conducting visits, ensuring data is entered in a timely manner and all queries are resolved, managing, and reporting adverse events, serious adverse events, protocol deviations, and implementing new protocol amendments.
    ~ Assures informed consent of human research subjects is 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, oversees routine monitoring of the data collected to ensure the safety of human research subjects.
    ~ children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons).
    ~ Ensures that adequate resources and facilities are available to carry out the proposed research study.
    ~ Ensures that everyone to whom a task is delegated, is qualified by virtue of education, training, and experience to perform the study.
    ~ iii) the potential adverse events associated with study participation and the steps to be taken to reduce potential risks; (and (v) data collection and record-keeping criteria.
    ~ Conducts 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.
    ~ Requests approval of any proposed modification to the research protocol or informed consent documents prior to implementing such modifications.
    ~ Maintains 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.
    ~ Works in close collaboration with company quality and clinical operational oversight.


    Language Ability:

    Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

    Strong knowledge of Microsoft Office Suite.
    Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    Location :
    On-Site , 7 Medical Pkwy Dallas, TX 75234

    Amount of Travel Required:
    % Schedule: Monday – Friday 8am-4:30pm
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