GENERAL PURPOSE:Under general direction with latitude for independent judgment, provides regulatory support and coordination of human subject clinical studies (i.e. clinical trials) at the Flaum Eye Institute (FEI), department of ophthalmology. Responsible for coordinating multiple clinical studies at any given time. Strong communication and clinical project management skills are required as this individual will be the primary contact with sponsors, clinical investigators, study staff, study subjects, collaborating departments, and other entities inside and outside of the medical center. May perform study related activities at the FEI medical center location or at one of the other FEI satellite offices as required. May supervise others.SPECIFIC RESPONSIBILITIES:25% Regulatory Responsibilities – Responsible for all aspects of research start-up including assisting in internal protocol and informed consent form review, regulatory/essential document preparation, submission and maintenance, maintaining study subject records, and submission to Institutional Review Boards. Reads and maintains a thorough understanding of clinical protocols and ensures all required elements related to a study conduct are completed as per protocol. Point person for monitoring visits and audits. May assist in study inspections or audits conducted by both internal groups (i.e. OHSP) or external groups (i.e. FDA, Sponsors).20% Patient Care – Responsible for coordinating study visits. Conducts the informed consent process when enrolling subjects into clinical studies. Works with clinical investigators and study subjects at to ensure subject compliance with medications/interventions and other protocol activities. Independently calibrates and sets up testing equipment as outlined on a per protocol basis. Completes clinical source documents during the subject’s visit, monitors adverse events and prepares study case report forms. May perform basic clinical testing (i.e. blood pressure measurement, point of care pregnancy tests, vision testing). Designs, develops, implements, monitors and manages systems and procedures for the purpose of tracking study progression.20% Subject Recruitment – Assists study staff in the recruitment and retention of subjects for current and upcoming studies. Recruit, prescreen, and enroll subjects for investigational studies. Review medical chart history with/on behalf of the Clinical Investigator to verify diagnosis and ensure patient meets study eligibility criteria. Create and distribute advertisements and flyers to increase enrollment in studies. Work with marketing representatives as appropriate to promote studies.15% Sponsor Interaction Serves as the point person for all sponsor communication and addresses questions as they arise. Coordinates and leads study monitoring visits as well as other sponsor visits such as Site Qualification visits, Site Initiation visits and Close out visits. Enters study data (i.e. into Electronic Data Capture system) and responds to queries as they arise.10% Training Responsibilities - Ensures that training is completed by ophthalmic technicians, research nurses, sub-Investigators and other study staff on study specific testing as per protocol. May provided oversight of technical staff regarding proper techniques for each subject visit. May provide study specific training to other study coordinators as needed to ensure cross coverage of studies. Keeps current with all federal, state, sponsor and institutional policies and laws, standard operating procedures, guidelines, and implements and monitors resulting study changes. Demonstrates accountability for continuous learning in accordance with Good Clinical Practice guidelines. Keeps current with industry standards, best practices, and trends in therapeutic areas relevant to research studies and designs. Implements and monitors resulting study changes. Completes study specific training as required by project.10% General – Identify new clinical trials through internet searches, sponsor contacts, and networking. Attend educational courses and seminars as appropriate to increase job knowledge. Keep up to date with current regulations for conducting clinical studies according to good clinical practices. Process and ship laboratory samples/specimens ensuring compliance with applicable specimen shipping regulations. Maintain active certification in shipping. May perform internal audits of other clinical studies being conducted at FEI. Assists with study budgets, contracts and research billing. May require occasional travel to Investigator Meetings as required by project. Other duties as requested.REQUIREMENTS:Bachelor’s degree and 3 years of experience in human subject research coordination; or an equivalent combination of education and experience. Knowledge of word processing and data analysis software. Professional Research Coordinator Certification (i.e., SoCRA or ACRP) preferred. Experience as Human Subject Research Coordinator I preferred. Phlebotomy Trained.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 ApplyAll applicants must apply online.EOE Minorities/Females/Protected Veterans/DisabledPay RangePay Range: 51,810 - $72,534 AnnuallyThe referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job’s compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.Apply for Job
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Location: School of Medicine & Dentistry
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