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<section><div>The Principal Investigator is responsible for ensuring that all research team members have appropriate education, training and qualifications to assume delegated study tests. Principal Investigator is responsible for ensuring that the conduct of the study is compliant with federal and industry guidance and regulations. Principal Investigators manage Phase 1 – Phase 4 studies, with demonstrated decision making capabilities. They will also engage with the sponsor’s monitor to discuss findings and ensure timely correction and documentation of any identified issues. </div> <div><span> </span></div> <div>The administrative structure of investigational sites under the decentralized site model requires a nontraditional approach. The Principal Investigator will be responsible for the oversight of trial conduct at one or more facilities where participants are located. Since the facilities may not be in close proximity, oversight will be provided in accordance with a well laid out Decentralized Clinical Trials Oversight Plan. </div> <div><span> </span></div> <div>This is a fully remote position, where the oversight for Sub Investigators, Research Coordinators, Laboratory Coordinators etc., is provided over email, phone, video conferencing etc. </div> <div><br></div> <div><b>Job Duties:</b></div> <div> <span>●</span><span> </span><span>Review the inclusion/exclusion criteria, endpoint criteria, and investigational article use with the internal research team.</span> </div> <div> <span>●</span><span> </span><span>Determine whether inclusion/exclusion criteria apply to the study population. </span> </div> <div> <span>●</span><span> </span><span>Maintain protocol compliance on all clinical trials/studies according to the International Conference on Harmonization-Good Clinical Practice (ICH-GCP), local regulations, and study protocol.</span> </div> <div> <span>●</span><span> </span><span>Oversee IRB review of study and ensure written IRB approval is obtained before initiating the study or instituting any changes to the protocol as approved. </span> </div> <div> <span>●</span><span> </span><span>Assess subject response to therapy, evaluate and address adverse experiences Meet regularly with the research team to discuss subject participation and protocol progress.</span> </div> <div> <span>●</span><span> </span><span>Meet with study assigned monitors at regular intervals.</span> </div> <div> <span>●</span><span> </span><span>Train Sub-Investigators and study staff members on protocol and protocol specific procedures.</span> </div> <div> <span>●</span><span> </span><span>Provide medical support to sub-investigators and study staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.</span> </div> <div> <span>●</span><span> </span><span>Maintain essential documents and records necessary for conduction of study.</span> </div> <div> <span>●</span><span> </span><span>Train on and implement Care Access Standard Operating Procedures. </span> </div> <div> <span>●</span><span> </span><span>Review sponsor provided safety reports.</span> </div> <div> <span>●</span><span> </span><span>Review and maintain accurate case report forms.</span> </div> <div> <span>●</span><span> </span><span>Sign off electronic case books as required by the study sponsor.</span> </div> <div> <span>●</span><span> </span><span>Provide clinical oversight and quality of the studies virtually. </span> </div> <div> <span>●</span><span> </span><span>Ensure the medical well-being and safety of the study participants, through the safe performance and execution of the clinical trials/studies. </span> </div> <div> <span>●</span><span> </span><span>Participate and engage in driving delivery of study targets, such as: participant recruitment, enrollment and retention.</span> </div> <div> <span>●</span><span> </span><span>Perform other duties as assigned.</span> </div> <div><br></div> <div><b>Required Qualifications:</b></div> <div> <span>●</span><span> </span><span>MD/DO License in good standing.</span> </div> <div> <span>●</span><span> </span><span>Willing to obtain multi-state licensure as needed</span> </div> <div> <span>●</span><span> </span><span>Board Certification in any of the following areas: Oncology, Hematology </span> </div> <div> <span>●</span><span> </span><span>Prior research experience required </span> </div> <div> <span>●</span><span> </span><span>Possess a thorough understanding of the requirements of clinical protocols.</span> </div></section><section><div><b>Diversity &amp; Inclusion</b></div> <div><span>We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. We do not discriminate based on race, sex, religion, color, national origin, gender identity, age, marital status, veteran status, or disability status.</span></div> <div><span> </span></div> <div><span>At Care Access, every day, we are advancing medical breakthroughs. We’re uniting</span></div> <div><span>standard patient care with cutting-edge treatments and research. Our work</span></div> <div><span>brings life-changing therapies to those in need and paves the way for newer and</span></div> <div><span>greater treatments to reach the world. We’re proud to advance these</span></div> <div><span>breakthroughs and work with the big players while engaging with the best</span></div> <div><span>physicians and caring for patients. Our team of experts is paving the way to</span></div> <div><span>take this vision forward through innovation and a unique technology-enabled</span></div> <div><span>service model. </span></div> <div><span> </span></div> <div><span>We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.</span></div> <div><span> </span></div> <div><span>Care Access is unable to sponsor work visas at this time.</span></div></section>