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WHAT
IN
SR. CLINICAL RESEARCH ASSOCIATE MILPTAS CA
Job
Abbott Medical Optics
US
-
Milpitas,
California
Job Code - 69076BR
Position - Full-Time
Job First Active on: Thursday, November 05, 2009
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JOB DESCRIPTION: SR. CLINICAL RESEARCH ASSOCIATE, MILPTAS, CA
As a Sr. Clinical Research Associate within the AMO Refractive Group, this position located in Milpitas, CA (Silicon Valley), (No relocation package) and responsible for the following:
• Develop, analyze and evaluate the execution of moderately complex human clinical research studies required to enter new products into the marketplace or to establish/expand product claims on existing AMO products, in compliance with state and federal regulations and corporate policies.
• Effectively manage multiple clinical sites (up to 20) to assure accurate and timely completion of studies, including developing project timelines and budgets.
• Study Initiation: Research background for studies and propose study design to manager. Under minimal supervision, prepare CTAs, de novo protocols and informed consent documents, and brochures. Ensure that approved originals are filed appropriately. Obtain completed pre-study documents. Create and maintain up to date and accurate study files. Request manufacture, document labeling and shipment of study materials. Approve draft labeling of investigational supplies. Identify and qualify investigators for potential study site. Conduct pre-study site visits. Prepare submissions for IRB approval and track activity and compliance. Conduct training and ensure site compliance with protocol procedures.
• Study Execution: Monitor case report forms (CRFs) for trends in safety, efficiency, and adherence to protocol. Ensure adherence to department SOPs. Ensure that final CRFs are accurate and complete; verify and approve data listings. Monitor progress of studies by communicating with sites and regional CRAs and traveling to sites. Conduct site visits, write detailed and accurate reports, and inform manager of adverse events and study progress. Ensure up to date and accurate study documentation at sites and in house. Motivate sites to complete study on a timely basis. Ensure that stock of clinical supplies is sufficient to meet study needs. Train and provide guidance to junior staff.
• Study Completion: Ensure availability of all final study documentation in case of FDA or research compliance audit. Independently review key variables and comments and present recommendations at technical review meetings. Interpret study results, write final reports, and obtain approvals. Conduct close out visits and coordinate the return of clinical supplies.
• Budget Planning: Participate in the study planning and budgeting. Log in CRFs for purpose of tracking site payments. Update accruals and submit check requests to management.
• Professional Enrichment: Attend related courses, seminars and meetings. Read professional journals and publications to stay abreast of regulations and study management to learn scientific area. Consistently increase knowledge regarding technology and/or physiology under study to ensure ability to monitor outcomes and interface with R&D for future product development.
REQUIREMENTS - QUALIFICATIONS: SR. CLINICAL RESEARCH ASSOCIATE, MILPTAS, CA
Basic Qualifications:
• 5 years of directly related experience in clinical research (CRA experience including on-site monitoring) or experience with ophthalmic technology and an additional 3 years of directly related experience
• Willingness to travel up to 40% (Includes international).
• Possess thorough knowledge of clinical trials monitoring, regulatory compliance and statistical reporting.
• Excellent knowledge of regulations governing clinical research including ICH/GCP guidelines.
• Excellent written and verbal communication skills and interpersonal skills.
• Ability to multi-task and remain flexible with changing priorities.
• Acute observational skills, analytical and conceptual capabilities.
• Ability to work independently with minimal supervision.
• Ability to reactively identify issues that may impact timelines.
• Ability to present at departmental or investigator meetings.
• Proficiency in the use of personal computers, including experience with Microsoft word processing, spread sheets (including basic analysis), email and web-browser applications.
Preferred Qualifications:
• CCRA,
• COA/COT
• Ophthalmic technology, specifically with refractive experience
• Experience with CTMS and/or EDC
Education:
BA or experience equivalent to 4 years of college in a science or health-related discipline with an additional 5 years in a relevant field; or experience with ophthalmic technology and an additional 3 years experience in a relevant field. See Skills/Experience Requirements
Abbott Medical Optics
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