<p>Mission Statement</p> <p>Michigan Medicine improves the health of patients, populations and communities through excellence in education, patient care, community service, research and technology development, and through leadership activities in Michigan, nationally and internationally. Our mission is guided by our Strategic Principles and has three critical components; patient care, education and research that together enhance our contribution to society.</p> <p>Job Summary</p> <p>Applicants can join a long-standing GI- Hepatology research group currently conducting clinical research in liver disease. There are ongoing observational registry studies as well as clinical trials involving novel therapies. Work is dynamic and multifaceted. The team is interested in adding a new research Tech/ assistant who brings curiosity, organizational skills, and critical thinking to the team.</p> <p>Responsibilities*</p> <ul> <li>Clinical coordinator- After completion of team training, learns to consent and enroll patients into observational studies and clinical trials. Performs study visits including pre-visit preparation, data and biosample collection during visits, shipping of materials and data entry. Arranges follow-up protocol study visits. Interfaces with data coordinating site and monitors. </li><li>Data coordinator- Works to address data queries, site monitoring visits, conference calls, data entry into web based systems </li><li>Regulatory- submission and management of IRB applications, ORIO?s, and adverse events. Assist with completing new e-research applications ; maintaining reg binders. Interfacing with sponsors. </li><li>Administrative- Collection and processing of biosamples and data, data entry, scheduling patients. Assisting with recruitment efforts with internal and external medical providers. Obtaining outside records and tissue samples. </li></ul> <p>Characteristic Duties and Responsibilities:</p> <p>Expert level knowledge, skills, and abilities within all 8 competency domains is expected:</p> <ul> <li>Scientific Concepts and Research Design </li><li>Ethical Participant Safety Considerations </li><li>Investigational Products Development and Regulation </li><li>Clinical Study Operations (GCPs) </li><li>Study and Site Management </li><li>Data Management and Informatics </li><li>Leadership and Professionalism </li><li>Communication and Teamwork </li></ul> <p>Supervision Received: This position reports directly to a faculty PI</p> <p>Supervision Exercised: None</p> <p>Required Qualifications*</p> <p>Clinical Research Assistant:</p> <ul> <li>High school diploma or GED is necessary </li></ul> <p>Clinical Research Technician:</p> <ul> <li>Associate degree in Health Science or an equivalent combination of related education and experience is necessary. </li><li>Minimum 1 year of directly related experience in clinical research and clinical trials is necessary. (Please review SoCRAs Definition of a Clinical Research Professional </li></ul>