- Serves as the principal investigator for clinical trials. 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.
- Screens and confirms subject eligibility for clinical trials in accordance with the Health Insurance Portability and Accountability Act (HIPAA) standards.
- Ensures privacy of human research subjects is protected, and the confidentiality of data is maintained.
- Conducts and manages clinical trials in accordance with the study protocol, GCP, ICH Guidelines and SOPs.
- 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.
- Supports appropriate additional safeguards 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 responds to all requests for information, including the timely submission of the research study for renewal.
- 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.
- Ensures 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.
- 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.
- Reports promptly any internal or external adverse event that is considered unexpected, serious, and possibly related to the study.
- Ensures 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.
- Ensures 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.
- Works in close collaboration with company quality and clinical operational oversight.
- 5+ years of clinical research experience as a PI or Sub-I
- MD / DO with an active license.
- 5+ years clinical research as a principal investigator and clinical skills experience
- MD / DO with license in good standing.
- 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.
- Strong analytical and decision-making capabilities that support clinical continuous improvement initiatives.
- Strong knowledge of Microsoft Office Suite.
- Must be a self-starter and highly motivated individual who can identify needs and proactively work to solve problems and gaps.
- While this role will not have direct reports initially, mentorship is expected.
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Principal Investigator MD/DO - Dallas, United States - EmVenio Research
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.
EmVenio Research offers competitive pay, a comprehensive benefits program and opportunities for learning and career development. We promote a diverse and inclusive workplace, and our team members have a voice in their work through surveys and town halls.
POSITION SUMMARY:
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.
POSITION RESPONSIBILITIES:
Education:
Ability to read, analyze, and interpret clinical trial protocols, general periodicals, professional journals, technical procedures, or governmental regulations. Ability to effectively present information and
Reasoning Ability:
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Knowledge, Skills and Abilities:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The preceding functions may not be comprehensive in scope regarding work performed by an employee assigned to this position classification. Management reserves the right to add, modify, change, or rescind the work assignments of this position. Management also reserves the right to arrange reasonable accommodation so that a qualified employee(s) can perform the essential functions of the position.
Location: On-Site, 7 Medical Pkwy Dallas, TX 75234
Amount of Travel Required: <10% of the time.
Schedule: Monday - Friday 8am-4:30pm
Compensation: $200,00-$230,000. The actual salary offered will carefully consider a wide range of factors, including your skills, qualifications, experience, and location.
