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Job #02285

About our client Our client provides a broad range of clinical research expertise in trial design, quality of life and health economics, event adjudication, data safety monitoring board, project management and data management. Position Location Senior Clinical Research Associate Massachusetts Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee overall conduct of multiple clinical trials 2) Establish and maintain primary communication with clinical sites and in-house and regional clinical research associates 3) Act as sponsor liaison to resolve any site related issues quickly and effectively 4) Review protocol and assist with and approve case report form design 5) Generate monitoring plan for assigned studies 6) Participate in the site/investigator selection system/process 7) Participate in completion of study related documents including informed consent form, protocol, case report forms, template source documents, training manuals, regulatory binder, and other resource materials 8) Conduct all types of monitor visits, qualifying site assessments, initiation, interim and closeout independently 9) Assist in the identification/evaluation of investigators and sites 10) Prepare and initiate confidential agreements 11) Assist in preparation of Clinical Site Agreements, including negotiation of site budgets 12) Assist in investigator and study staff training 13) Develop informed consent templates 14) Manage investigative sites and track/report study site progress 15) Review and sign-off on investigator payments and co-monitor as needed 16) Mentor less experienced Clinical Research Associates 17) Manage, coordinate, attend and participate in investigator and coordinator meetings 18) Participate and/or chair team meetings 19) Provide centralized site support, communication and coordination to assure accurate and timely completion of all contracted activities 20) Provide ongoing site management support through project completion 21) Facilitate general communication among the research centers, project teams, sponsors and site monitors Requirements 1) BS degree in Science/Health related field (Masters preferred) 2) Maximum 5 years of clinical research experience in a pharmaceutical, biotech or CRO setting with a minimum of 2 years of independent clinical monitoring 3) Ability to understand clinical trials research through exposure to research protocols in a variety of therapeutic areas and knowledge of internal SOPs, FDA/ICH guidelines and GCPs 4) Ability to work independently and in a team environment