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Job #02976

About our client Our client is a global CRO that offers full-service clinical research capabilities across all therapeutic areas. Our client has successfully completed drug, biologic, device and diagnostics trials in an efficient and cost-effective manner for US, Japanese and European developers as well as CROs. The company has an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of its employees. Position Location Clinical Research Associate Hillsburgh, New Jersey Salary Highly competitive package, commensurate with experience Responsibilities 1) Conduct all aspects of site monitoring visits (pre-study selection, site initiation, interim monitoring and closeout) 2) Ensure site staff has proper materials and training to safely conduct the study 3) Verify the ongoing suitability of investigators and sites throughout the conduct of a clinical study 4) Verify the following up of informed consent procedures and protocol requirements to ensure the protection of study patients 5) Ensure AEs and SAEs are reported as per protocol guidelines and SOP sponsor 6) Prepare accurate and timely monitoring visit reports as well as expense reports 7) Ensure investigational product is accounted for and substantiating documentation is maintained 8) Prepare materials for clinical study conduct (e.g., ICF template, study manual, CRF, site regulatory binder, subject status tracking, etc.) 9) Ensure proper maintenance of site’s regulatory binder and Investigator files through regular reviews 10) Review qualifications of investigators and sites as well as make recommendations for their participation in a clinical study 11) Complete tasks as well as travel in an economical method to ensure prudent use of company resources 12) Track the day-to-day progress of clinical site activities and update the appropriate clinical status tracker at regular intervals 13) Ensure data integrity by careful source document reviewing, CRF entry validation and data clarification 14) Plan work schedules to meet project timelines 15) Maintain effective communication (written, oral and /or electronic contacts) 16) Complete all clinical, corporate and project-specific training 17) Attend meetings as required 18) Assist with reviewing of monitoring visit reports 19) Perform other tasks as required Requirements 1) BS in a scientific discipline or health-related field 2) 5+ years of clinical monitoring experience 3) Experience in Phases I – III of drug development 4) Prior experience in dermatological/topical pharmaceuticals a plus 5) Working knowledge of GCP, ICH guidelines and FDA regulations 6) Proven experience in getting clinical trials off the ground 7) Experience in managing trials from beginning to end 8) Ability to work without instructions on routine CRA work 9) Ability to work with only general instructions on new assignments 10) Ability to resolve routine issues independently 11) Excellent problem-solving skills in managing clinical sites 12) Tactful and diplomatic in dealing with study coordinators and physicians 13) Proficiency in computers 14) Excellent communication (oral and written) and organizational skills 15) Ability to work efficiently (independently or in a team environment)