Study Management Associate Jobs in Michigan (NOW HIRING)

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.

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.

ESSENTIAL FUNCTIONS/AREAS OF ACCOUNTABILITY:

• 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.