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Job #02852

About our client Our client is a publicly traded pharmaceutical company headquartered in New Jersey with over 10 years of success in the development and commercialization of OTC therapeutics. The company has some of the strongest financial indicators in the industry, an experienced management team and a robust pipeline. They also offer an empowering corporate culture that is focused on the professional development and advancement of clinical team members. Position Location Senior Clinical Research Associate New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee and monitor CRO activities 2) Initiate study sites 3) Ensure that each site has trial materials and training site staff adhering to trial-specific and industry standards 4) Monitor the trial throughout its duration by visiting study sites regularly 5) Verify that the data entered on to the CRFs is consistent with source data and site source documents 6) Collect completed CRFs from study sites (CRO, hospital or general practice) 7) Write initiation, monitoring and closeout visit reports 8) File and collate trial regulatory documentation as well as site-generated reports 9) Verify clinical supply accountability and reconciliation 10) Conduct study site closeout (on completion of the trial) 11) Discuss clinical results and observations with medical, statistical, bioanalytical and pharmacokinetic scientists as well as clinical writers 12) Facilitate and monitor on-time fulfillment of study enrollment quotas, including protocol criteria exceptions 13) Serve as Clinical Trial Leader for selected trials and lead a multifunctional team through clinical study activities 14) Ensure appropriate GCP-compliant archiving of study documentation and correspondence 15) Assist with reviewing and resolution of data queries 16) Work with multidisciplinary project teams in preparing and implementing clinical development plans 17) Assist with developing clinical trial protocol summaries, protocols and ICFs and ensure that program meets GCP and SOP requirements 18) Prepare and implement project-specific training programs and training materials for study site 19) Assist in procuring and managing contracts with CROs as well as developing study budgets 20) Provide clinical research expertise in support of other departments and line functions 21) Contribute to preparation of IND/IMPD as well as other regulatory documents and submissions (as needed) 22) Develop knowledge of study indications and therapeutic areas related to projects to better interact with investigators and external study coordinators 23) Support the development of cost estimates and proposals for clinical conduct of studies 24) Manage and execute clinical research programs for assigned products 25) Provide technical input to study protocols 26) Manage assigned studies through all phases of the study process 27) Plan, forecast and oversee logistics 28) Manage timelines 29) Work with CROs in developing study operation documents and data collection forms (CRFs) 30) Train and manage study sites 31) Represent the company at study sites 32) Monitor/document study conduct per protocol, in relation to GCP guidelines and SOPs 33) Provide a functional contact for clients, ensuring regular project updates and ongoing customer satisfaction 34) Develop and use appropriate information systems to report project progress and performances 35) Make effective presentations at all organizational levels Requirements 1) BS in Sciences or RN 2) 5 – 8 years of clinical research experience in pharmaceutical products (not medical devices) 3) Expertise in reviewing final clinical study reports and protocols 4) Experience in monitoring studies for GCP compliance 5) Ability to work independently 6) Willingness to travel – up to 25% (initially traveling may be higher)