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Job #02702

About our client Our client is a global leader in the production of OTC products, based in New York. The company has marketed products, an experienced management team and an empowering corporate culture that is focused on the professional development of its employees; this is a great opportunity for the right candidate! Position Location Clinical Compliance Specialist New York Salary Highly competitive package, commensurate with experience Responsibilities 1) Assess quality systems/scientific reports and clinical data 2) Conduct internal and external monitoring of clinical investigator sites, CROs and vendors 3) Generate monitoring reports 4) Render compliance assurance presentations to Clinical Affairs, affiliates, clinical investigators, R&D, Regulatory and/or QA personnel 5) Coordinate, collect and distribute regulatory documents for the initiation of clinical studies and maintain those documents 6) Assist the Director and project managers with tracking of training and compliance documents as per FDA requirements 7) Maintain a database of audit findings, qualifying investigator sites and vendors, and implement a grading system 8) Serve as Study File Manager 9) Reconcile study’s drug returns for compliance assessment and initiate destruction processes 10) Review periodic monitoring reports for ongoing clinical trials 11) Follow-up on corrective and preventive actions to ensure continuing efficacy 12) Support the generation of submission reports to the FDA 13) Assist with the distribution of IND safety letters 14) Oversee maintenance of retention samples at sites 15) Track training and compliance documents for all staff members 16) Review and provide feedback on clinical study reports 17) Maintain departmental SOPs and assess compliance periodically 18) Develop SOPs to ensure regulatory compliance 19) Work closely with Pharmacovigilance and Regulatory Groups to monitor AEs/SAEs and report to the FDA 20) Maintain pharmacovigilance data in a database Requirements 1) Bachelor’s degree in Physical/Life Sciences, Nursing, or Pharmacy or equivalent experience 2) 3 – 5 years of pharmaceutical clinical research and/or QA monitoring experience 3) Experience in auditing in a cGMP environment or training in auditing (RAB/related) 4) Experience in dermatology preferred 5) In-depth knowledge of current and pending FDA regulations, 21CFR and ICH guidelines 6) Excellent knowledge of cGMPs, GCPs and SOPs 7) Ability to highlight areas in need of improvement in a manner that is constructive and non-confrontational