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Job #02504

About our client Our client is a biotechnology company. The company, which was founded in the early part of this century, is a specialist in the field of ophthalmic diseases. It is developing medications to treat the primary causes of these diseases and alleviate their symptoms. The company strives to improve/protect the eyesight of patients with these diseases. Position Location Clinical Research Associate (In-House) New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee CRO, investigational site selection, performance and compliance 2) Provide the firm/management with status reports and recommendations 3) Represent the firm at pre-study site visits, site initiation visits and in other venues (e.g., the firm's sponsored dinners at professional meetings) 4) Prepare or provide input to the development and review of clinical study documents, including protocols, case report forms, monitoring plans, etc. 5) Prepare presentations and training materials 6) Oversee and coordinate site certifications as required by the protocol 7) Review monitoring visit reports and other correspondence relevant to the clinical sites 8) Participate in clinical team meetings, offer suggestions or recommendations for clinical operations processes 9) Schedule meetings, develop and circulate meeting agendas, take and distribute meeting minutes 10) Host monthly study coordinator meetings 11) Oversee vendor (e.g., randomization system, central labs, image management, etc.) selection, contracting and performance 12) Manage clinical drug supplies (packaging, labeling, distribution, inventory and re-supply oversight) Requirements 1) BA/BS in Health or Biological Science 2) 3+ years of field monitoring experience on pivotal trials 3) CRA certification a plus 4) Experience in ophthalmology research a plus 5) Experience in CRF design, database design, data management (edit check development, data review and query writing) 6) Familiarity with coding dictionaries 7) Experience in supply chain management 8) Experience in vendor selection and oversight 9) Knowledge of medical terminology, GCP and regulations for clinical trials 10) Computer skills – MS Word, MS Excel, MS Outlook, MS PowerPoint, Internet browsers 11) Willingness to travel – 10-25%