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Senior Clinical Research Associate / Clinical Project Manager
Qualified candidates will have strong oral and written communication skills with monitoring, study management, and SOP-development experience. The ideal candidate will be highly adaptable, proactive, deadline- and detail-oriented, and will maintain a high level of professional expertise through recent industry training and familiarity with clinical research publications. The candidate must be able to work independently in accomplishing assigned tasks by effective planning, communication, execution, and maintenance of cutting-edge knowledge of assigned therapeutic area by reviewing scientific and medical literature, industry news, and other sources. Biologics and Ophthalmology experience a plus.
# Plan and implement early-phase clinical research studies within budget and on schedule
# Coordinate and lead study team meetings and update the Development Team on timelines and progress toward milestones.
# Coordinate activities of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives.
# Contribute to the development of study documentation including protocol review, creating study manuals, and designing CRFs.
# Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies both in the field and in-house.
# Participate in study site selection; review and update site specific consent forms; track patient accrual and study progress via standard reports; assure patient eligibility; document protocol deviations/violations; and manage adverse event reporting.
# Oversee clinical monitoring from site qualification to site closure visits and assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, and medical records. Evaluate and analyze clinical data.
# Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing.
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