University of Rochester Sr Human Subject Res Coord - 214086 in Rochester, New York
Sr Human Subject Res Coord Job ID 214086Location School of Medicine & Dentistry Full/Part Time Full-Time Favorite Job Regular/Temporary Regular Opening
Full Time 40 hours Grade 055 Ophthalmology M&DSchedule
8:30 AM-5 PMResponsibilities
This position will be responsible for all phases of project implementation related to the Flaum Eye Institute’s (FEI) human-based translational research studies. The individual will 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. The individual will provide input and/or prepare relevant components (e.g. human subjects section) of grant proposals and other applications to obtain funding. They will generate and maintain IRB protocols and regulatory materials pertaining to projects being managed. They will coordinate and manage the human subjects regulatory components of multiple projects in scientific collaboration with other entities across the University, including but not limited to Center for Visual Science (CVS), the Clinical Translational Science Institute (CTSI), Laboratory Medicine, and Biostatistics/Computational Biology. The coordinator can also serve as project liaison between industry sponsors, principal investigators, internal and external regulatory entities, and auxiliary and collaborating laboratories across the University. The coordinator will be expected to provide FEI staff and faculty with training on federal, state, and local regulations, Good Clinical Practice, as well as sponsor and/or institutional policies and practices related to human subject research. This position may supervise others.
Under general guidance, with administrative and scientific latitude for exercising independent judgment, is responsible for the implementation and coordination of research projects involving human subjects within FEI and with respect to collaborations between FEI and other University entities such as the Center for Visual Science and departments both within the Medical Center and River Campus. Works towards the establishment, growth and maintenance of new and novel human subjects research projects and applications in areas of vision research pertaining to the detection, prevention and treatment of diseases impacting vision.
Human-Based Translational Research Development
Assist scientific investigators in the preparation and submission of relevant portions of new grant applications (e.g. Human Subjects section of NIH grants) involving human-based translational research for multiple FEI research investigators. Apply a high level of expertise and knowledge of ophthalmic research and clinical science to successfully support and help design studies that meet the strategic planning goals for FEI translation research program, while adhering to regulatory requirements. Attend educational courses and seminars as appropriate for the purpose of increasing job knowledge and its application to the job. Keep up-to-date with current regulations, university policies, and industry trends for conducting human-based studies according to Good Clinical Practices.
Collaborate with other University departments and centers of excellence inside and outside the University, requiring strong communication and interpersonal skills at a senior level. Create and maintain an awareness of human-based research initiatives and participation/recruitment opportunities among FEI clinical and basic science faculty in a way that supports establishing collaborative partnerships. Collaborate with both clinical and research faculty in the design and implementation of collaborative research opportunities by attending and participating in scientific research development meetings and planning sessions with FEI investigators.
Ensures appropriate billing of all study related activities meeting institutional requirements and maintaining adequate systems controls. Ensures that all project related expenses fall within the scope of the study protocols and study budgets. Oversees financial compensation of study participants; orders research related supplies, materials, and equipment as needed within appropriate grant and accounting guidelines.
Regulatory Oversight and Quality Assurance
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 translational human subject research start-up including: collaborating with investigators on protocol development, protocol review, regulatory document preparation, consent form preparation, and submissions to 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 and principal investigators for existing studies. Maintain regulatory documentation, reports and analyses; develop database management tools for monitoring, analyzing and reporting on study participants. Utilize sponsor-provided software packages as necessary. Responsible for planning, staffing, and hosting all sponsor-monitoring visits; accountable for keeping industry sponsors and 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.
Recruit, prescreen, and enroll subjects for investigational studies. Review medical chart history with the principal investigators to verify diagnosis and ensure patient meets eligibility criteria. Create and distribute 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 with prospective candidate patients as detailed in an IRB approved consent form.
Study Visit Procedures
Participate in informed consent process. Assist principal investigators with study visits to ensure subject compliance with medications and other protocol activities. Advise/train/mentor students and trainees assigned to new projects. Coordinate with study certified clinical technicians so that necessary ophthalmic procedures, measurements, and diagnostic testing are conducted. Ability to learn and perform basic clinical skills such as obtaining vital signs and ophthalmic testing.
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. Has completed Continuous Learning for Administrators of Sponsored Programs (CLASP) certification or able to become certified within one year of assuming role.
Master’s Degree in an appropriate, related field preferred. 5 years of related clinical and research experience. Experience in conducting ophthalmic clinical studies desired; ability to perform basic patient clinical work-ups (e.g. take patient history, vitals, blood pressure,) and ophthalmic patient work-ups and diagnostic tests; 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.How To Apply
All applicants must apply online.
EOE Minorities/Females/Protected Veterans/Disabled