Ophthalmic Consultants of Boston (OCB) was established in 1969 to offer patients the highest quality eye care and laser/surgical treatment. OCB is the premier eye care provider in the region with nineteen practice locations in the greater Boston area, South Shore, and Cape Cod. OCB ophthalmologists use the most advanced diagnostic, laser and surgical techniques available, and their level of care has earned Ophthalmic Consultants of Boston a national and international reputation for excellence. Are you a team player, energized by superb patient care and impressed by efficient operations of a world-class health care provider? Are you looking to continuously bringing your skills to the next level while getting recognized by the great work you do?  Participates in training of new research coordinators and assistants on GCP guidelines, SOPs, and clinical skills, and serves as a resource for study team members on questions and issues as they arise. Oversees or directly coordinates multiple research studies, including enrolling subjects, conducting study visits, maintaining data, and communicating with study sponsors, monitors, and regulatory personnel in writing and in person. We are currently hiring a Senior Research Coordinator/Technician for our Retina Team. This is a multi-site location opportunity working in our Weymouth, Waltham, and Boston locations. Performance Requirements: + Working knowledge of theory and application of FDA and ICH Good Clinical Practice (GCP) guidelines.  + Excellent organizational, interpersonal, computer, and verbal/written communication skills. + Working knowledge of anatomy and physiology of the eye.  Understanding of the theory and the workings behind specific testing.  Possesses a clear understanding of pertinent tests, including the “why,” “how,” and “when” behind pertinent testing.  Knowledge of ocular diseases.  Knowledge of systemic diseases and their impact on the eyes. + Ability to travel between OCB office locations such as Boston, Weymouth, and Waltham, as needed. Education and Experience: + Preferred: + COT/COA and + Clinical Research Coordinator (CRC) certification. + At least 3 years research coordinator experience required. + Bachelor of Science degree preferred. Example of Responsibilities: + Participates in training of new research coordinators and research assistants on GCP guidelines, team policies/ procedures, and clinical skills. + Functions as helpful and resourceful liaison between research team and clinical teams to ensure productive use of limited resources such as physician time, exam lanes, supplies and equipment. + Coordinates Investigator-initiated studies. + Identifies the need for new or revised research policies and procedures and brings these to Research Manager or Research Director as appropriate. + Assists Investigator/Practice Manager/Practice Research Director in design, updating, and implementation of research programs standard operating procedures. Also includes all responsibilities of a Research Coordinator:   + Actively applies knowledge of FDA and ICH Good Clinical Practice guidelines throughout study performance to ensure compliance with these standards. + Primarily responsible for acquiring detailed knowledge of components of assigned studies, including protocol, masking, scheduling, reporting and related issues and ensuring all aspects of study performance are in accordance with the protocol. + Obtains informed consent, coordinates screening of possible candidates, and enrolls participants in clinical trials, in accordance with team’s enrollment goals. + Conducts study patient visits through direct patient care (including manifest refractions, visual acuity examinations, intraocular pressure readings, electrocardiograms, phlebotomy, etc,) and through coordination with Testing Department and study fellows and attending physicians. + Maintains accurate accountability of investigational drug/product. + Maintains accurate and comprehensive study files, including completion and maintenance of source documents, case report forms, regulatory documents and required logs. + Function as primary liaison between Investigator, participants, sponsor, monitor, and regulatory bodies for assigned studies: + Function as primary liaison between Investigator, participants, sponsor, monitor, and regulatory bodies for assigned studies: Obtains and maintains approval of institutional review boards and FDA, as required. Establishes and maintains a professional working relationship with all study participants.  Communicates with Investigator, Practice Manager and other team members about progress of studies and issues as they arise. Communicates with study sponsor and monitor and promptly and accurately seeks resolution of and responds to monitor queries.   Benefits Offered: + Health & Dental Insurance- eligible 1st day of employment + Paid time off and paid holidays + Health & Dependent Reimbursement Accounts + 401(k) Plan with company contribution + Company paid Life and LTD Insurance + Employee discounts To find out more about OCB, please visit our website at www.eyeboston.com. OCB is an Equal Opportunity Employer.  All Employees must be fully vaccinated.   Powered by JazzHR