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Job #02857

About our client Our client is a specialty pharmaceutical and medical device company. The company focuses on developing and commercializing new products for orthopedic and general surgery markets. Position Location Clinical Research Associate I/II New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Participate in planning, designing and execution of high-quality clinical studies to ensure safety and effectiveness of products 2) Work with confidential patient and company data 3) Interface with internal and external stakeholders 4) Participate in site qualification and initiation process, including scheduling the monitoring activities with site personnel 5) Oversee one or more concurrent clinical studies 6) Track and report progress of studies, including patient enrollment/screening, data collection, adverse event documentation, protocol deviations, budgets and FAQs 7) Assist the Director in developing, negotiating and executing site contracts, budget and payment plans (final approval from the Director) 8) Assist the Director with development, approval and distribution of study-related documents, including Case Report Forms (CRFs), study protocols, study manuals and other study tools to investigational sites and review committees 9) Draft informed consents under direct supervision 10) Gather documents and information for Clinical Investigator and core laboratory selection 11) Manage device accountability, inventory and distribution 12) Supervise the device complaint/malfunction process and tracking 13) Monitor compliance with study protocols and site’s adherence to global regulatory guidelines 14) Prepare and participate in presentation of protocols and other study conduct requirements at study initiations at investigational sites (when needed) 15) Oversee subject screening and enrollment at assigned clinical sites 16) Manage distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites with Sponsor Central File as well as for audit readiness 17) Assist in planning, preparing and distributing materials for Investigator and Coordinator meetings as well as for study-related training 18) Assist the query writing and resolution process (as required) 19) Identify and gather missing or incomplete data from the investigational sites 20) Review Case Report Forms for clinical content 21) Assist the Director with developing/maintaining project timeline, managing study budgets and preparing routine operations reports 22) Conduct site visits (as necessary) 23) Act as a company liaison working with clinical sites to resolve any site related issues quickly and effectively 24) Provide on-call help for sites along with site training on protocol or site management 25) Coordinate site compliance, including the development and implementation of corrective actions for addressing noncompliance issues 26) Assist with study site audits 27) Track internal and external audits of investigational sites and analyze outcomes 28) Assist clinical management with regulatory submissions and other reports (as required) 29) Oversee ongoing literature searches for therapeutic area/product specific reviews 30) Assist the development and/or maintenance of clinical infrastructure such as the drafting or reviewing of SOPs and work instructions Requirements 1) Bachelor's degree in Science/health-related field (e.g. Biology, Nursing, Biomedical or Veterinary Sciences) preferred 2) 1-year experience in clinical/scientific research, nursing or medical devices/pharmaceutical industry 3) 6 months of clinical monitoring experience 4) Knowledge of FDA regulatory requirements 5) Excellent written communication skills 6) Willingness to travel – up to 25%