Sr Human Subject Res Coord - University of Rochester

Responsibilities **Position Summary:** To serve as the Senior Human Subject Research Coordinator for the Research Center in the Department of Anesthesiology and Perioperative Medicine. The Senior Human Subject Research Coordinator will report to the Director of the Anesthesiology Clinical Research Center and will be responsible for coordinating the efforts of faculty, residents, staff, Research Subjects Review Board, and funding agencies in regard to investigator-initiated studies, sponsored research projects, training grants, and pharmaceutical clinical trials This individual will also be responsible for all phases of project implementation related to human subjects research studies in the Department of Anesthesia. The individual will assist faculty in the development of protocols and oversee all regulatory materials pertaining to active and prospective projects. The individual will also provide administrative leadership and research collaboration at a senior level by establishing and maintaining relationships with Investigators, internal and external regulatory entities, study staff, vendors, and industry sponsors. They will also serve as project liaison between study sponsors, principal investigators, internal and external regulatory entities, and auxiliary entities across the University. They will recruit study subjects, conduct study visits, and thoroughly document all aspects of the study. Along with the Director of Clinical Research, this individual will assist with mentoring and providing supervision of research clinical staff. **Scope:** Under guidance from the Vice-Chair of Research and the Director of the Anesthesiology Clinical Research Center, and with administrative and scientific latitude for exercising independent judgment, is **responsible for the overall management of the Research Center in the Department of Anesthesiology** , and the implementation, management, and coordination of all research projects involving human subjects. Assist faculty growth and maintenance of new and novel human subjects research projects and applications in areas of Anesthesia and Perioperative Medicine. **Responsibilities:** _Research Leadership (20%)_ + Works with the Director of the Anesthesiology Clinical Research Center to coordinate all activities of the Anesthesiology Clinical Research Center, including meetings of the Research Division and protocol development. _Regulatory Oversight and Quality Assurance (30%)_ + Oversee human subject research activities for single or multiple sites. Develop, implement, and evaluate study subject requirement strategies, information and data systems, and study management systems. Create, plan, develop, implement and manage study design, budgets, protocols, consent forms, and policies that may include multiple therapeutic areas. Create, develop, review, and approve study-specific procedures, manuals, and documents. Accountable for all aspects of internal and external research study compliance, standards of quality, regulatory requirements, and reporting obligations for each project/research study. Responsible for all aspects of human subject research start-up, including: collaborating with investigators on protocol development, protocol review, regulatory document preparation, consent form preparation, and submissions to the Institutional Review Board. Interact with Research Subjects Review Board to ensure all requirements, documentation, and start-up requirements are met for existing and new protocols. + Serve as liaison between sponsors, principal investigators, and University entities (e.g., RSRB, WIRB, OHSP, ORPA) for existing studies with the ability to proficiently and compliantly maneuver through the approval processes and then assure compliance throughout the research process. Manage the regulatory documentation, reports and analyses; develop database management tools (e.g., REDCap) for monitoring, analyzing and reporting on study metrics. Utilize sponsor-provided software packages as necessary. Responsible for planning, staffing, and hosting all sponsor-monitoring visits; accountable for keeping industry sponsors and other funding sources informed about the data, reporting, regulatory and compliance details, overall project status, deliverables and deadlines for each project. Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. _Additional Responsibilities (10%)_ + Represent sites, providers, study team, patients, study participants and the University overseeing, and maintaining positive working relationships to achieve effective results in clinical research studies within the department. Responsible for supporting the contacts and relationships between and among Principal Investigators (PI), research staff, study sites, sponsors and regulatory agencies + Advise, train, and mentor other study coordinators, students and trainees assigned to new projects. Willingness to travel periodically for Investigator Meetings. Assist faculty with manuscript preparation for publication in peer-reviewed medical literature and on abstracts/posters for local, state and national level conferences. + Keep current with all federal, state, sponsor and institutional policies and laws, SOPs and guidelines. Manage and evaluates resulting study changes. Demonstrates accountability for continuous learning in accordance with GCPs. Keeps current with industry standards, best practices and trends in therapeutic areas relevant to research studies. _Patient Recruitment (20%)_ + Recruit, prescreen and enroll subjects for investigational studies. Review medical record data with the principal investigators to verify the diagnosis and ensure the patient meets eligibility criteria. Create and distribute IRB-approved advertisements and flyers to increase enrollment in studies. Promote scientific studies with marketing representatives as appropriate to generate patient and community interest and participation. Maintain working knowledge of all open protocols and explain relevant protocols in lay terms from an IRB-approved consent form. Develop, document, and implement Standard Operating Procedures (SOPs) and ensure adherence to established SOPs. _Study Visit Procedures (20%)_ + Understand, implement, and follow study protocols and conduct multiple studies independently. Work collaboratively with other staff and departments to complete research protocols, including performing study procedures such as assessing participant eligibility and recruitment, arranging necessary schedules and procedures, performs basic clinical skills such as obtaining vital signs, ECG testing, phlebotomy, and other protocol specific activities. + Participate in the ongoing informed consent process, ensuring that human subjects understand what is expected during the course of participating trial. Record data from source documentation into case report forms (either paper or electronic) with awareness and attention to the requirements for accuracy, completeness, and timeliness. + Establish study-specific processes for distribution of study funds. Manage expenses, equipment and study materials. Monitor operating and financial reports and documents for review and analysis. Other projects and job duties as assigned. **Qualifications:** + Bachelor’s degree with major course work in an appropriate health, social or technical field, 5 years of related experience; or an equivalent combination of education and expertise. Graduate Degree in business or Health Administration and Certified Clinical Research Coordinator preferred. + Experience in conducting human clinical research studies desired; ability to perform basic patient clinical work-ups (e.g., phlebotomy, vitals, blood pressure); knowledge of FDA regulations, International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) guidelines. Professional research certification such as CCRC, CCRA, CCRP (i.e., SOCRA or ACRP) highly desirable. + Individuals with data management or statistical expertise are encouraged to apply. Individuals with the requisite expertise would have expanded responsibilities, including participation in literature reviews, research design, data management, statistical analyses, and manuscript preparation. These functions would be carried out in collaboration with clinical and research faculty, with support from the Department biostatistician and data scientist. + Excellent interpersonal, presentation, and communication skills, including written communication. + Advanced knowledge of software programs (e.g., Excel, PowerPoint, Endnote, Adobe Acrobat). The University of Rochester is committed to fostering, cultivating, and preserving a culture of equity, diversity, and inclusion to advance the University’s mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion/creed, sex, sexual orientation, citizenship status, or any other status protected by law. This commitment extends to the administration of our policies, admissions, employment, access, and recruitment of candidates from underrepresented populations, veterans, and persons with disabilities consistent with these values and government contractor Affirmative Action obligations. **How To Apply** All applicants must apply online. _EOE Minorities/Females/Protected Veterans/Disabled_ **Location:** Medical Faculty Group **Full/Part Time:** Full-Time **Opening:** Full Time 40 hours Grade 055 Anesthes & Periop Medicine **Schedule:** 8 AM-4:30 PM